International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by New York University School of Medicine
Sponsor:
Collaborators:
New York University
Stanford University
Albany Stratton VA Medical Center
Cedars-Sinai Medical Center
Columbia University
Duke University
East Carolina University
Emory University
Harvard University
Massachusetts General Hospital
Montreal Heart Institute
University of British Columbia
University of Missouri, Kansas City
Vanderbilt University
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01471522
First received: November 10, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~8000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT.

SPECIFIC AIMS

A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death or nonfatal myocardial infarction in participants with SIHD and at least moderate ischemia over an average follow-up of approximately 4 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT. The primary endpoint is time to centrally adjudicated cardiovascular death or nonfatal myocardial infarction.

B. Secondary Aims Major: To compare angina-related quality of life between groups. Other secondary aims include: a) comparing the incidence of all-cause death; the components of the primary endpoint; the composite endpoint of cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure; stroke; and stroke combined with cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure between randomized groups; and b) comparing health resource utilization, costs, and cost-effectiveness between groups.

Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III

Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III

Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III


Condition Intervention
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Procedure: cardiac catheterization
Procedure: coronary artery bypass graft surgery
Procedure: percutaneous coronary intervention
Behavioral: Lifestyle
Drug: Medication

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Time to first occurrence of cardiovascular death or nonfatal myocardial infarction. [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Angina control per Seattle Angina Questionnaire (SAQ) Angina Frequency Scale [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Disease specific quality of life per Seattle Angina Questionnaire (SAQ) Quality of Life Scale [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Nonfatal myocardial infarction [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Resuscitated cardiac arrest [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Hospitalization for unstable angina [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Hospitalization for heart failure [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Composite of cardiovascular death, nonfatal myocardial infarction, stroke, resuscitated cardiac arrest, hospitalization for unstable angina or heart failure. [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Health resource utilization, costs, and cost effectiveness [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 8000
Study Start Date: July 2012
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Invasive Strategy (INV)
Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy.
Procedure: cardiac catheterization
Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization.
Other Name: cath
Procedure: coronary artery bypass graft surgery
Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, "cabbage"). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart.
Other Name: CABG
Procedure: percutaneous coronary intervention
Percutaneous coronary intervention may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.
Other Name: PCI
Behavioral: Lifestyle
diet, physical activity, smoking cessation
Other Name: Behavior change
Drug: Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Other Name: Pharmacologic Therapy
Active Comparator: Conservative Strategy
Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms.
Behavioral: Lifestyle
diet, physical activity, smoking cessation
Other Name: Behavior change
Drug: Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Other Name: Pharmacologic Therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least moderate ischemia on an ischemia test
  • Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
  • Participant is willing to give written informed consent
  • Age ≥ 21 years

Exclusion Criteria:

  • LVEF < 35%
  • History of unprotected left main stenosis >50% on prior coronary computed tomography angiography (CCTA) or prior cardiac catheterization (if available)
  • Finding of "no obstructive CAD" (<50% stenosis in all major epicardial vessels) on prior CCTA or prior catheterization, performed within 12 months
  • Coronary anatomy unsuitable for either PCI or CABG
  • Unacceptable level of angina despite maximal medical therapy
  • Very dissatisfied with medical management of angina
  • History of noncompliance with medical therapy
  • Acute coronary syndrome within the previous 2 months
  • PCI within the previous 12 months
  • Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
  • History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia not due to a transient reversible cause
  • NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months
  • Non-ischemic dilated or hypertrophic cardiomyopathy
  • End stage renal disease on dialysis or estimated glomerular filtration rate (eGFR) <30mL/min (not an exclusion criterion for CKD ancillary trial, see CKD ancillary trial, Section 18)
  • Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
  • Allergy to radiographic contrast that cannot be adequately pre-medicated, or any prior anaphylaxis to radiographic contrast
  • Planned major surgery necessitating interruption of dual antiplatelet therapy (note that patients may be eligible after planned surgery)
  • Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
  • Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable)
  • Patient who, in the judgment of the patient's physician, is likely to have significant unprotected left main stenosis (Those who are able to undergo CCTA will have visual assessment of the left main coronary artery by the CCTA core lab)
  • Enrolled in a competing trial that involves a non-approved cardiac drug or device
  • Inability to comply with the protocol
  • Exceeds the weight or size limit for CCTA or cardiac catheterization at the site
  • Canadian Cardiovascular Society Class III angina of recent onset, OR angina of any class with a rapidly progressive or accelerating pattern
  • Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina
  • High risk of bleeding which would contraindicate the use of dual antiplatelet therapy
  • Cardiac transplant recipient
  • Prior CABG, unless CABG was performed more than 12 months ago, and coronary anatomy has been demonstrated to be suitable for PCI or repeat CABG to accomplish complete revascularization of ischemic areas (CCC approval required)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471522

Contacts
Contact: Judith S Hochman, MD 212-263-4225 ISCHEMIA@nyumc.org
Contact: Stephanie Mavromichalis 212-263-4225 ISCHEMIA@nyumc.org

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Fadi Hege       ischemia@nyumc.org   
United States, Arizona
Scottsdale Healthcare Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joseph Klag       ischemia@nyumc.org   
United States, California
Cedars Sinai Medical Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Jon Kobashigawa       ischemia@nyumc.org   
John Muir Health Recruiting
Concord, California, United States, 94520
Contact: Gary Gershony       ischemia@nyumc.org   
Alliance Clinical Research Recruiting
Laguna Hills, California, United States, 92653
Contact: Michael Moran       ischemia@nyumc.org   
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Gabriel Vorobiof       ischemia@nyumc.org   
Palo Alto Medical Foundation Research Institute Recruiting
Palo Alto, California, United States, 94087`
Contact: bob Hu       ischemia@nyumc.org   
Kaiser Permanente- San Jose Recruiting
San Jose, California, United States, 94538
Contact: James Jang       ischemia@nyumc.org   
Torrance Memorial Medical Center Recruiting
Torrance, California, United States, 90505
Contact: Ray Wyman       ischemia@nyumc.org   
United States, Colorado
South Denver Cardiology Associates, PC Recruiting
Littleton, Colorado, United States, 80120
Contact: Ira Dauber       ischemia@nyumc.org   
Medical Center of the Rockies Recruiting
Loveland, Colorado, United States, 80538
Contact: Thomas Downes       ischemia@nyumc.org   
United States, Delaware
Nanticoke Cardiology Associates Recruiting
Seaford, Delaware, United States, 19973
Contact: Angel Alicea       ischemia@nyumc.org   
United States, Florida
Daytona Heart Group Recruiting
Daytona Beach, Florida, United States, 32114
Contact: Glenn Rayos       ischemia@nyumc.org   
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: John Petersen       ischemia@nyumc.org   
Malcom Randall V.A. Medical Center Recruiting
Gainesville, Florida, United States, 32608
Contact: David Wichester       ischemia@nyumc.org   
Mercy Hospital Recruiting
Miami, Florida, United States, 33133
Contact: Manuel Mayor       ischemia@nyumc.org   
Sarasota Memorial Hospital Recruiting
Sarasota, Florida, United States, 34239
Contact: Michael Mumma       ischemia@nyumc.org   
Cardiovascular Center of Sarasota Recruiting
Sarasota, Florida, United States, 34239
Contact: Mahfouz El Shahawy       ischemia@nyumc.org   
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Arthur Labovitz       ischemia@nyumc.org   
United States, Georgia
Saint Joseph's Hospital of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Contact: Stephen Frohwein       ischemia@nyumc.org   
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Arshed Quyyumi       ischemia@nyumc.org   
Atlanta V.A. Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Kreton Mavromatis       ischemia@nyumc.org   
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Amit Patel       ischemia@nyumc.org   
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Khaled Dajani       ischemia@nyumc.org   
United States, Indiana
Indiana University / Krannert Institute of Cardiology Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Ronald Mastouri       ischemia@nyumc.org   
United States, Iowa
Iowa Heart Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Gardar Sigurdsson       ischemia@nyumc.org   
United States, Kentucky
University of Kentucky Hospital Recruiting
Lexington, Kentucky, United States, 40536
Contact: David Booth       ischemia@nyumc.org   
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: James Stafford         
Contact       ischemia@nyumc.org   
NIH Heart Center at Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Contact: Greg Kumkumian       ischemia@nyumc.org   
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Peter Stone       ischemia@nyumc.org   
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Claudia Hochberg       ischemia@nyumc.org   
VA Boston Healthcare System Recruiting
West Roxbury, Massachusetts, United States, 02132
Contact: Scott Kinlay       ischemia@nyumc.org   
Saint Vincent Hospital at Worcester Medical Center Recruiting
Worcester, Massachusetts, United States, 01608
Contact: Joseph Hannan       ischemia@nyumc.org   
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Khaled Nour       ischemia@nyumc.org   
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: David Wohns       ischemia@nyumc.org   
William Beaumont Health Systems Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Steven Almany       ischemia@nyumc.org   
Covenant Medical Center Recruiting
Saginaw, Michigan, United States, 48602
Contact: Scott Martin       ischemia@nyumc.org   
Beaumont Hospital Recruiting
Troy, Michigan, United States, 48085
Contact: Phillip Kraft       ischemia@nyumc.org   
Michigan Heart, PC Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Herbert Aronow       ischemia@nyumc.org   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Uma Valeti       ischemia@nyumc.org   
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Todd Miller       ischemia@nyumc.org   
United States, Missouri
Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: James O'Keefe       ischemia@nyumc.org   
United States, New Jersey
Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Contact: Richard Goldweit       ischemia@nyumc.org   
North Shore University Hospital Recruiting
Manhasset, New Jersey, United States, 11030
Contact: Bruce Rutkin       ischemia@nyumc.org   
AtlantiCare Regional Medical Center Recruiting
Pomona, New Jersey, United States, 08240
Contact: Kevin Marzo       ischemia@nyumc.org   
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Navin Budhwani       ischemia@nyumc.org   
Hackensack University Medical Cetner Recruiting
Saddle Brook, New Jersey, United States, 07663
Contact: William Salerno       ischemia@nyumc.org   
United States, New York
Albany Associates in Cardiology Recruiting
Albany, New York, United States, 12205
Contact: Eric Roccario       ischemia@nyumc.org   
Capital Cardiology Associates Recruiting
Albany, New York, United States, 12211
Contact: Lance Sullenberger       ischemia@nyumc.org   
Albany Medical Center Hospital Recruiting
Albany, New York, United States, 12208
Contact: Mohammad El-Hajjar       ischemia@nyumc.org   
NYU-HHC Lincoln Medical and Mental Health Center Recruiting
Bronx, New York, United States, 10451
Contact: Lekshmi Dharmarajan       ischemia@nyumc.org   
Jacobi Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Jay Meisner       ischemia@nyumc.org   
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Robert Ostfeld       ischemia@nyumc.org   
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: John Heitner       ischemia@nyumc.org   
Woodhull Hospital Recruiting
Brooklyn, New York, United States, 11229
Contact: Ronny Cohen       ischemia@nyumc.org   
NYU-HHC Kings County Hospital Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Ronald Pedalino       ischemia@nyumc.org   
NYU Hudson Valley Cardiology Recruiting
Cortlandt Manor, New York, United States, 10567
Contact: Glenn Hamroff       ischemia@nyumc.org   
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Kevin Marzo       ischemia@nyumc.org   
Lenox Hill Hospital Recruiting
New, New York, United States, 10075
Contact: Kirk Garratt       ischemia@nyumc.org   
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Robert Pyo       ischemia@nyumc.org   
NYU New York Medical Associates Recruiting
New York, New York, United States, 10022
Contact: Dennis Goodman       ischemia@nyumc.org   
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Harmony R Reynolds, MD    212-263-4225    ISCHEMIA@nyumc.org   
Principal Investigator: Harmony R Reynolds, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Sabahat Bokhari       ischemia@nyumc.org   
Saint Luke's-Roosevelt Hospital Center Recruiting
New York, New York, United States, 10025
Contact: Jacqueline Tamis-Holland       ischemia@nyumc.org   
Cardiology Associates of Schenectady P.C. Recruiting
Schenectady, New York, United States, 12309
Contact: Steven Weitz       ischemia@nyumc.org   
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Luis Gruberg       ischemia@nyumc.org   
United States, North Carolina
Asheville Cardiology Associates Recruiting
Asheville, North Carolina, United States, 28803
Contact: William Abernethy       ischemia@nyumc.org   
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Khouri       ischemia@nyumc.org   
United States, North Dakota
Sanford-Fargo Recruiting
Fargo, North Dakota, United States, 58122
Contact: Thomas Haldis       ischemia@nyumc.org   
United States, Ohio
Louis Stokes V.A. Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jonathan Goldberg       ischemia@nyumc.org   
Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: Arnold Good       ischemia@nyumc.org   
United States, Oklahoma
Oklahoma Heart Institute Recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Edward Martin       ischemia@nyumc.org   
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97201
Contact: Michael Shapiro       ischemia@nyumc.org   
Providence Heart and Vascular Institute Recruiting
Portland, Oregon, United States, 97225
Contact: Charles Cannan       ischemia@nyumc.org   
United States, Pennsylvania
Saint Luke's Hospital and Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18018
Contact: Francis Burt       ischemia@nyumc.org   
Holy Spirit Hospital Cardiovascular Institute Recruiting
Camp Hill, Pennsylvania, United States, 17011
Contact: Christopher Spizzieri       ischemia@nyumc.org   
Doylestown Cardiology Associates Recruiting
Doylestown, Pennsylvania, United States, 18901
Contact: Joseph McGarvey       ischemia@nyumc.org   
Conemaugh Valley Memorial Hospital Recruiting
Johnstown, Pennsylvania, United States, 15905
Contact: Robert Stenberg       ischemia@nyumc.org   
V.A. Pittsburgh Healthcare System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: David Zielinski       ischemia@nyumc.org   
Lehigh Valley - Buxmont Cardiology Recruiting
Sellersville, Pennsylvania, United States, 18960
Contact: Paul Hermany       ischemia@nyumc.org   
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Paul Gordon       ischemia@nyumc.org   
Brigham and Women's Cardiovascular Associates at Kent Hospital Recruiting
Warwick, Rhode Island, United States, 02886
Contact: Chester Hedgepeth       ischemia@nyumc.org   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: William Wince       ischemia@nyumc.org   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: John McPherson       ischemia@nyumc.org   
Saint Thomas Hospital Recruiting
Nashville, Tennessee, United States, 373203
Contact: Andrew Zurick       ischemia@nyumc.org   
United States, Texas
Texas Heart and Vascular Research Recruiting
Austin, Texas, United States, 78745
Contact: Nima Amjadi       ischemia@nyumc.org   
V.A. North Texas Health Care System Recruiting
Dallas, Texas, United States, 75216
Contact: Subhash Banerjee       ischemia@nyumc.org   
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Ihab Hamzeh       ischemia@nyumc.org   
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Deepika Gopal       ischemia@nyumc.org   
Audie Murphy V.A. Recruiting
San Antonio, Texas, United States, 78229
Contact: Robert Chilton       ischemia@nyumc.org   
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Michael Salerno       ischemia@nyumc.org   
Cardiovascular Associates, Ltd. Recruiting
Chesapeake, Virginia, United States, 23320
Contact: Wayne Old       ischemia@nyumc.org   
Valley Health Clinical Research Dept Recruiting
Winchester, Virginia, United States, 22601
Contact: Jason Call       ischemia@nyumc.org   
United States, Washington
University of Washington Medical Center Recruiting
Bellevue, Washington, United States, 98004
Contact: Alec Moorman       ischemia@nyumc.org   
United States, Wisconsin
Gundersen Lutheran Medical Center Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Sampoornima Setty       ischemia@nyumc.org   
Argentina
Fundacion Favaloro Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1093AAS
Contact: Julio Figal       ischemia@nyumc.org   
Hospital Privado de Comunidad Recruiting
Mar del Plata, Buenos Aires, Argentina, 7600
Contact: Alvaro Facta       ischemia@nyumc.org   
Instituto Medico DAMIC Recruiting
Cordoba, CBA, Argentina, 5009
Contact: Luis Guzman       ischemia@nyumc.org   
Sanatorio Mayo S A Recruiting
Ciudad de Sante Fe, Santa Fe, Argentina, 3000
Contact: Alberto Licheri       ischemia@nyumc.org   
Instituto Cardiovascular de Rosario Recruiting
Rosario, Santa Fe, Argentina, 2000
Contact: Gerardo Zapata       ischemia@nyumc.org   
Clinica Romagosa and Clinica De La Familia Recruiting
Cordoba, Argentina, 5000
Contact: Javier Courtis       ischemia@nyumc.org   
Clinica Del Prado Recruiting
Cordoba, Argentina, 5000
Contact: Lilia Schiavi       ischemia@nyumc.org   
Australia, South Australia
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: Majo Joseph       ischemia@nyumc.org   
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: James Shaw       ischemia@nyumc.org   
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Stephen Duffy       ischemia@nyumc.org   
Australia, Western Australia
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia, 6000
Contact: James Rankin       ischemia@nyumc.org   
Austria
LKH Graz West Austria Recruiting
Graz, Stmk, Austria, 8020
Contact: Herwig Schuchlenz       ischemia@nyumc.org   
Medical University Innsbruck Recruiting
Innsbruck, Tyrol, Austria, A-6020
Contact: Guy Joseph Friedrich       ischemia@nyumc.org   
University of Vienna Allgemeines Krankenhaus Recruiting
Vienna, Wien, Austria, 1090
Contact: Irene Lang       ischemia@nyumc.org   
Wilhelminenhospital of Community Vienna Recruiting
Vienna, Wien, Austria, A-1160
Contact: Kurt Huber       ischemia@nyumc.org   
Belgium
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Antwerpen, Belgium
Contact: Christiaan Vrints       ischemia@nyumc.org   
AZ Turnhout Campus-Saint Elisabeth Recruiting
Turnhout, Antwerpen, Belgium
Contact: Harry Lesseliers       ischemia@nyumc.org   
UZ Leuven/Gasthuisberg University Hospital Recruiting
Leuven, Brabant, Belgium
Contact: Kaatje Goetschalckx       ischemia@nyumc.org   
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Kevin Bainey       ischemia@nyumc.org   
Canada, British Columbia
Saint Paul's Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Robert Boone       ischemia@nyumc.org   
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Graham Wong       ischemia@nyumc.org   
Canada, Ontario
West Lincoln Memorial Hospital Recruiting
Grimsby, Ontario, Canada
Contact: Andy Lam       ischemia@nyumc.org   
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada
Contact: Shamir Mehta       ischemia@nyumc.org   
University Hospital Recruiting
London, Ontario, Canada
Contact: Dennis Humen       ischemia@nyumc.org   
Dr. James Cha (Private Practice affiliated Lakeridge Helath of Oshawa) Recruiting
Oshawa, Ontario, Canada
Contact: James Cha       ischemia@nyumc.org   
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada
Contact: Renee Hessian       ischemia@nyumc.org   
Scarborough Cardiology Research Recruiting
Scarborough, Ontario, Canada
Contact: Paul Galiwango       ischemia@nyumc.org   
Saint Michael's Hospital Recruiting
Toronto, Ontario, Canada
Contact: Asim Cheema       ischemia@nyumc.org   
University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Amar Uxa       ischemia@nyumc.org   
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada
Contact: Gilbert Gosselin       ischemia@nyumc.org   
CSSS du Sud de Lanaudiere Recruiting
Terrebonne, Quebec, Canada
Contact: Denis Phaneuf       ischemia@nyumc.org   
Centre Hospitalier de Regional Trois-Rivieres Recruiting
Trois-Rivieres, Quebec, Canada
Contact: Ariel Diaz       ischemia@nyumc.org   
Canada
Quebec Heart and Lung Institute Recruiting
Quebec, Canada
Contact: Eric Larose       ischemia@nyumc.org   
China, Beijing
Fuwai Hospital Recruiting
Beijing, Beijing, China
Contact: Hongbing Yan       ischemia@nyumc.org   
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Jiyan Chen       ischemia@nyumc.org   
China, Hubei
Wuhan Union Hospital, Tongji Medical College, Huazhong Science and Tech University Recruiting
Wuhan, Hubei, China
Contact: Qiutang Zeng       ischemia@nyumc.org   
Wuhan Asia Heart Hospital Recruiting
Wuhan, Hubei, China
Contact: Xi Su       ischemia@nyumc.org   
China, Shandong
Qingdao Fuwai Hospital Recruiting
Qingdao, Shandong, China
Contact: Ying Yang       ischemia@nyumc.org   
China
TEDA International Cardiovascular Hospital Recruiting
Tianjing, China
Contact: Wenhua Lin       ischemia@nyumc.org   
France
Centre Hospitalier Sud Francilien Recruiting
Corbeil-Essonnes cedex, Ile de France, France
Contact: Eric Nicollet       ischemia@nyumc.org   
Bichat Hospital Recruiting
Paris, Ile-de-France, France
Contact: Philippe-Gabriel Steg       ischemia@nyumc.org   
Grenoble University Hospital Recruiting
Grenoble, Isere, France
Contact: Gilles Barone-Rochette       ischemia@nyumc.org   
Germany
University of Ulm Recruiting
Ulm, BW, Germany
Contact: Peter Bernhardt       ischemia@nyumc.org   
Universitatsklinikum Bonn Recruiting
Bonn, NRW, Germany
Contact: Georg Nickenig       ischemia@nyumc.org   
Universitaetsklinikum Duesseldorf Recruiting
Dusseldorf, NRW, Germany
Contact: Malte Kelm       ischemia@nyumc.org   
Praxisklinik Herz Und Gefaesse Recruiting
Dresden, Saxony, Germany
Contact: Rolf Doerr       ischemia@nyumc.org   
Hungary
University of Pecs, Heart Institute Recruiting
Pecs, Baranya, Hungary
Contact: Tamas Simor       ischemia@nyumc.org   
University of Szeged Recruiting
Szeged, Szeged Megyei Varos, Hungary
Contact: Albert Varga       ischemia@nyumc.org   
George Gottsegen National Institute of Cardiology Recruiting
Budapest, Hungary
Contact: Geza Fontos       ischemia@nyumc.org   
Szent Istvan Hospital Recruiting
Budapest, Hungary
Contact: Andras Vertes       ischemia@nyumc.org   
Semmelweis University Recruiting
Budapest, Hungary
Contact: Bela Merkely       ischemia@nyumc.org   
India
Gurunanak CARE Hospital Recruiting
Hyderabad, AP, India
Contact: Johann Christopher       ischemia@nyumc.org   
Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore-Karnataka Recruiting
Bangalore, Karnataka, India
Contact: Cholenahally Manjunath       ischemia@nyumc.org   
Medical College Calicut Recruiting
Calicut, Kerala, India
Contact: Mangalath Krishnan       ischemia@nyumc.org   
Amrita Institute of Medical Sciences and Research Centre Recruiting
Eanakulam, Kerala, India
Contact: Navin Mathew       ischemia@nyumc.org   
Hero DMC Heart Institute Unit Dayanand Medical Recruiting
Ludhiana, Punjab, India
Contact: Gurpreet Wander       ischemia@nyumc.org   
Frontier Lifeline Hospital Recruiting
Chennai, Tamilnadu, India
Contact: Ayalur Narayanaswamy       ischemia@nyumc.org   
Madras Medical Mission Recruiting
Chennai, Tamilnadu, India
Contact: Ajit Mullasari       ischemia@nyumc.org   
Ram Manohar Lohia Hospital Recruiting
Delhi, India
Contact: Neeraj Pandit       ischemia@nyumc.org   
All India Institute of Medical Sciences Recruiting
New Delhi, India, 110029
Contact: Balram Bhargava       ischemia@nyumc.org   
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Arthur Kerner       ischemia@nyumc.org   
Assuta Medical Centers Recruiting
Tel-Aviv, Israel
Contact: Tali Sharir       ischemia@nyumc.org   
Italy
Second University of Naples - Monaldi Hospital Recruiting
Napoli, Campania, Italy
Contact: Paolo Calabra       ischemia@nyumc.org   
GB Morgagni Hospital-Forli Recruiting
Forli, Emilia-Romagna, Italy
Contact: Marcello Galvani       ischemia@nyumc.org   
UOC Cardiologia Ospedale Santo Spirito Roma Recruiting
Rome, Lazio, Italy
Contact: Roberto Ricci       ischemia@nyumc.org   
Ospedali Riuniti of Ancona Recruiting
Ancona, Marche, Italy
Contact: Gian Perna       ischemia@nyumc.org   
Policlinico di Monza Recruiting
Monza, MB, Italy
Contact: Andrea Mortara       ischemia@nyumc.org   
Istituto Clinico Humanitas Recruiting
Rozzano, Milano, Italy
Contact: Lorenzo Monti       ischemia@nyumc.org   
Azienda Ospedaliera S. Croce e Carle Recruiting
Cuneo, Piemonte, Italy
Contact: Emanuela Racca       ischemia@nyumc.org   
UO Cardiologia Ospedale SS Cosma e Damiano Recruiting
Pescia, Pistoia, Italy
Contact: William Vergoni       ischemia@nyumc.org   
Cardiocentro Ticino Recruiting
Lugano, Ticino, Italy
Contact: Tiziano Moccetti       ischemia@nyumc.org   
Ospedale Civile S. Antonio Abate Recruiting
Tolmezzo, Udine, Italy
Contact: Antonia di Chiara       ischemia@nyumc.org   
University of Padua Recruiting
Padua, Veneto, Italy
Contact: Giuseppe Tarantini       ischemia@nyumc.org   
Ospedale Regionale Umberto Parini Recruiting
Aosta, Italy
Contact: Marco Sicuro       ischemia@nyumc.org   
OORR Foggia Recruiting
Foggia, Italy
Contact: Matteo di Biase       ischemia@nyumc.org   
Ospedale S. Camillo Recruiting
Rome, Italy
Contact: Roberto Violini       ischemia@nyumc.org   
Ospedale di Circolo e Fondazione Macchi Recruiting
Varese, Italy
Contact: Edoardo Verna       ischemia@nyumc.org   
Japan
Keio University Hospital Recruiting
Shinjuka, Tokyo, Japan
Contact: Keiichi Fukuda       ischemia@nyumc.org   
Lithuania
Vilnius University Hospital Santariskes Clinic Recruiting
Vilnius, Lithuania
Contact: Aleksandras Laucevicius       ischemia@nyumc.org   
Mexico
IMSS Recruiting
Benito Juarez, DF, Mexico
Contact: Jorge Escobedo       ischemia@nyumc.org   
New Zealand
Waikato Hospital Recruiting
Hamilton, Waikato, New Zealand
Contact: Gerard Devlin       ischemia@nyumc.org   
Poland
Polyclinic Independent Public Health Department, 4th Military Clinical Hospital Recruiting
Wroclaw, Dolny Slask, Poland
Contact: Krysztof Reczuch       ischemia@nyumc.org   
Lower Silesia Specialist Hospital T Marciniak Recruiting
Wrocław, Dolny Śląsk, Poland
Contact: Krystyna Loboz-Grudzien       ischemia@nyumc.org   
Medical University of Lodz Recruiting
Lodz, Lodzkie, Poland
Contact: Jarozlaw Drozdz       ischemia@nyumc.org   
John Paul II Hospital Recruiting
Krakow, Maopolskie, Poland
Contact: Grzegorz Gajos       ischemia@nyumc.org   
2 nd Department of Coronary Artery Disease Recruiting
Warsaw, Mazovian, Poland
Contact: Hanna Szwed       ischemia@nyumc.org   
2 nd Department of Coronary Artery Disease Recruiting
Warsaw, Mazowieckie, Poland
Contact: Adam Witkowski       ischemia@nyumc.org   
Coronary and Structural Heart Diseases Department, Institute of Cardiology, Warsaw Recruiting
Warsaw, Mazowieckie, Poland
Contact: Marcin Demkow       ischemia@nyumc.org   
Independent Public Central Clinical Hospital, Medical University of Warsaw Recruiting
Warsaw, Mazowieckie, Poland
Contact: Tomasz Mazurek       ischemia@nyumc.org   
Department of Internal Medicine, Infant Jesus Teaching Hospital, Medical University of Warsaw Recruiting
Warszawa, Mazowieckie, Poland
Contact: Piotr Pruszczyk       ischemia@nyumc.org   
University Hospital in Bialystok Recruiting
Bialystok, Podlaskie, Poland
Contact: Wlodzimierz Musial       ischemia@nyumc.org   
Silesian Center for Heart Diseases Recruiting
Zabrze, Wojewodztwo Slaskie, Poland
Contact: Zbigniew Kalarus       ischemia@nyumc.org   
Silesian Center for Heart Disease Recruiting
Zabrze, Wojewodztwo Slaskie, Poland
Contact: Lech Polonski       ischemia@nyumc.org   
Bieganski Hospital Medical University of Lodz Recruiting
Lodz, Poland
Contact: Jaroslaw Kasprzak       ischemia@nyumc.org   
University Hospital of the Lord's Transfiguration Recruiting
Poznan, Poland
Contact: Maciej Lesiak       ischemia@nyumc.org   
Russian Federation
Bakulev Scientific Center for Cardiovascular Surgery Recruiting
Moscow, Gorod Moskva, Russian Federation
Contact: Leo Bockeria       ischemia@nyumc.org   
Almnazov Federal - Heart Blood and Endocrinology Centre Recruiting
Saint-Petersburg, Russian Federation
Contact: Elena Demchenko       ischemia@nyumc.org   
Saudi Arabia
King Abdul Aziz Cardiac Center Recruiting
Riyadh, Central Province, Saudi Arabia
Contact: Mouaz Al-Mallah       ischemia@nyumc.org   
Serbia
Dedinje Cardiovascular Institute Recruiting
Belgrade, Savski Venac, Serbia
Contact: Petar Otasevic       ischemia@nyumc.org   
Institute of Cardiovascular Diseases, Vojvodina - Sremska Kamenica Recruiting
Sremska Kamenica, Vojvodina, Serbia
Contact: Nada Cemerlic Adjic       ischemia@nyumc.org   
Cardiology Clinic at Clinical Center of Serbia Recruiting
Belgrade, Serbia
Contact: Branko Beleslin       ischemia@nyumc.org   
University Clinical Hospital Zvezdara Recruiting
Belgrade, Serbia
Contact: Milica Dekleva       ischemia@nyumc.org   
Clinical Center of Serbia Recruiting
Belgrade, Serbia
Contact: Petar Seferovic       ischemia@nyumc.org   
Cardiovascular Institute Dedinje, Belgrade, Serbia Recruiting
Belgrade, Serbia
Contact: Ljiljana Jovovic       ischemia@nyumc.org   
Clinic for cardiovascular diseases, Clinical Center Nis Recruiting
Nis, Serbia
Contact: Svetlana Apostolovic       ischemia@nyumc.org   
Singapore
National Heart Centre Singapore Recruiting
Singapore, Singapore
Contact: Terrance Chua       ischemia@nyumc.org   
Spain
Hospital de Bellvitge Recruiting
Barcelona, Spain
Contact: Guillermo Sanchez-Elvira       ischemia@nyumc.org   
Hospital de Sant Pau Barcelona Recruiting
Barcelona, Spain
Contact: Alessandro Sionis       ischemia@nyumc.org   
Hospital Universitario La Paz Recruiting
Madrid, Spain
Contact: Jose Luis Lopez Sendon       ischemia@nyumc.org   
Sweden
Uppsala University Recruiting
Uppsala, Sweden
Contact: Claes Held       ischemia@nyumc.org   
United Kingdom
The Belfast Health and Social Care Trust Recruiting
Belfast, Antrim, United Kingdom
Contact: Nicola Johnston       ischemia@nyumc.org   
Luton and Dunstable Hospital Recruiting
Luton, Berdfordshire, United Kingdom
Contact: Christopher Travill       ischemia@nyumc.org   
Papworth Hospital NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom
Contact: Stephen Hoole       ischemia@nyumc.org   
Peterborough City Hospital Recruiting
Peterborough, Cambs, United Kingdom
Contact: Denise Braganza       ischemia@nyumc.org   
The James Cook University Hospital Recruiting
Middlesbrough, Cleveland, United Kingdom
Contact: Mark de Belder       ischemia@nyumc.org   
Royal Bournemouth Hospital Recruiting
Bournemouth, Dorset, United Kingdom
Contact: Peter Okane       ischemia@nyumc.org   
Dorset County Hospital Recruiting
Dorchester, Dorset, United Kingdom
Contact: Fraser Witherow       ischemia@nyumc.org   
The University of Hull/Castle Hill Hospital Recruiting
Cottingham, East Yorkshire, United Kingdom
Contact: Angela Hoye       ischemia@nyumc.org   
Central Manchester University Hospital Recruiting
Manchester, Lancashire, United Kingdom
Contact: Helen Dormand       ischemia@nyumc.org   
Royal Oldham Hospital Recruiting
Oldham, Lancashire, United Kingdom
Contact: Jolanta Sobolewska       ischemia@nyumc.org   
Northwick Park Hospital-Royal Brompton Hospital, London Recruiting
Harrow, Middlesex, United Kingdom
Contact: Roxy Senior       ischemia@nyumc.org   
Ulster Hospital Recruiting
Belfast, Northern Ireland, United Kingdom
Contact: Patrick Donnelly       ischemia@nyumc.org   
Craigavon Area Hospital Recruiting
Craigavon, Northern Ireland, United Kingdom
Contact: Andrew Moriarty         
University Hospital of Wales - Cardiff Recruiting
Cardiff, Wales, United Kingdom
Contact: Tim Kinnaird       ischemia@nyumc.org   
Edinburgh Heart Centre Recruiting
Edinburgh, United Kingdom
Contact: Peter Henriksen       ischemia@nyumc.org   
University College London Hospital Recruiting
London, United Kingdom
Contact: Derek Hausenloy       ischemia@nyumc.org   
Sponsors and Collaborators
New York University School of Medicine
New York University
Stanford University
Albany Stratton VA Medical Center
Cedars-Sinai Medical Center
Columbia University
Duke University
East Carolina University
Emory University
Harvard University
Massachusetts General Hospital
Montreal Heart Institute
University of British Columbia
University of Missouri, Kansas City
Vanderbilt University
Investigators
Study Chair: Judith S Hochman, MD New York University
Principal Investigator: David J Maron, MD Stanford University
  More Information

Additional Information:
Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01471522     History of Changes
Other Study ID Numbers: 713, 1U01HL105907
Study First Received: November 10, 2011
Last Updated: April 3, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014