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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01471522
Recruitment Status : Active, not recruiting
First Posted : November 15, 2011
Last Update Posted : March 19, 2018
New York University
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
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

Brief Summary:

The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter randomized controlled trial with 5179 randomized participants with moderate or severe ischemia on stress testing. A blinded coronary computed tomography angiogram (CCTA) was performed in most participants with eGFR ≥60 mL/min/1.73m2 to identify and exclude participants with either significant unprotected left main disease (≥50% stenosis) or those without obstructive CAD (<50% stenosis in all major coronary arteries). Of 8720 participants enrolled, those that had insufficient ischemia, ineligible anatomy demonstrated on CCTA or another exclusion criterion, did not go on to randomization. Eligible participants were then assigned at random to a routine invasive strategy (INV) with cardiac catheterization followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cardiac catheterization and revascularization reserved for those who fail OMT.


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, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure in participants with SIHD and moderate or severe ischemia over an average follow-up of approximately 3.5 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT.

B. Secondary Aims Secondary aims are to determine whether an initial invasive strategy compared to a conservative strategy will improve: 1) the composite of CV death or MI; 2) angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire Angina Frequency and Quality of Life scales; 3) all-cause mortality; 4) net clinical benefit assessed by including stroke in the primary and secondary composite endpoints; and 5) individual components of the composite endpoints.

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 or disease Intervention/treatment Phase
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 Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
Study Start Date : July 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Composite of cardiovascular death, myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure [ Time Frame: ~3.5 year follow-up ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01471522

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Yuma Regional Medical Center
Yuma, Arizona, United States
United States, California
Cedars Sinai Medical Center
Beverly Hills, California, United States, 90211
UCSF - Fresno Community Regional Medical Center
Fresno, California, United States
Alliance Clinical Research
Laguna Hills, California, United States, 92653
UCLA Medical Center
Los Angeles, California, United States, 90095
University of Southern California
Los Angeles, California, United States
University of California Irvine Medical Center
Orange, California, United States
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94087`
V.A. Palo Alto Health Care System
Palo Alto, California, United States
Kaiser Permanente- San Jose
San Jose, California, United States, 94538
Coastal Heart Medical Group
Santa Ana, California, United States
Torrance Memorial Medical Center
Torrance, California, United States, 90505
United States, Colorado
Empirican PRN LLC
Denver, Colorado, United States
South Denver Cardiology Associates, PC
Littleton, Colorado, United States, 80120
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
United States, Connecticut
West Haven VA Medical Center
West Haven, Connecticut, United States
United States, Delaware
Nanticoke Cardiology Associates
Seaford, Delaware, United States, 19973
United States, Florida
Daytona Heart Group
Daytona Beach, Florida, United States, 32114
Malcom Randall V.A. Medical Center
Gainesville, Florida, United States, 32608
Mayo Clinic
Jacksonville, Florida, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, United States, 34239
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
University of South Florida
Tampa, Florida, United States, 33606
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
Atlanta V.A. Medical Center
Decatur, Georgia, United States, 30033
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana University / Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
United States, Iowa
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Iowa Heart Center
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky Hospital
Lexington, Kentucky, United States, 40536
V.A. Medical Center - Lexington
Lexington, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
United States, Louisiana
Cardiovascular Specialists of Southwest Louisiana, LLC
Lake Charles, Louisiana, United States
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, United States, 20814
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Boston Medical Center
Boston, Massachusetts, United States, 02118
VA Boston Healthcare System
West Roxbury, Massachusetts, United States, 02132
Saint Vincent Hospital at Worcester Medical Center
Worcester, Massachusetts, United States, 01608
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Spectrum Health
Grand Rapids, Michigan, United States, 49503
McLaren Northern Michigan
Petoskey, Michigan, United States
Covenant Medical Center
Saginaw, Michigan, United States, 48602
Providence Hospital and Medical Center
Southfield, Michigan, United States
Michigan Heart, PC
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Minneapolis V.A. Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States, 55905
HealthEast Saint Joseph's Hospital
Saint Paul, Minnesota, United States
United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Kansas City V.A. Medical Center
Kansas City, Missouri, United States
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
North Shore University Hospital
Manhasset, New Jersey, United States, 11030
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States, 08240
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Hackensack University Medical Cetner
Saddle Brook, New Jersey, United States, 07663
United States, New York
Albany Medical Center Hospital
Albany, New York, United States, 12208
Capital Cardiology Associates
Albany, New York, United States, 12211
Samuel Stratton VA Medical Center
Albany, New York, United States
NYU-HHC Lincoln Medical and Mental Health Center
Bronx, New York, United States, 10451
Jacobi Medical Center
Bronx, New York, United States, 10461
NYU-HHC Kings County Hospital Center
Brooklyn, New York, United States, 11203
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Woodhull Hospital
Brooklyn, New York, United States, 11229
Empirican PRN LLC / Advanced Cardiology Group
Buffalo, New York, United States
NYU Hudson Valley Cardiology
Cortlandt Manor, New York, United States, 10567
New York University - Langone Cardiovascular Associates
Flushing, New York, United States
Mid Valley Cardiology
Kingston, New York, United States
Winthrop University Hospital
Mineola, New York, United States, 11501
New York University School of Medicine
New York, New York, United States, 10016
NYU New York Medical Associates
New York, New York, United States, 10022
Saint Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
Beth Israel Medical Center
New York, New York, United States
V.A. New York Harbor Healthcare System - Manhattan Campus
New York, New York, United States
Cardiology Associates of Schenectady P.C.
Schenectady, New York, United States, 12309
Northwell Health-Staten Island
SI, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Asheville Cardiology Associates
Asheville, North Carolina, United States, 28803
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, North Dakota
Fargo, North Dakota, United States, 58122
United States, Ohio
Cincinnati V.A. Medical Center
Cincinnati, Ohio, United States
Louis Stokes V.A. Medical Center
Cleveland, Ohio, United States, 44106
Grant Medical Center
Columbus, Ohio, United States, 43215
United States, Oklahoma
Oklahoma City V.A. Medical Center
Oklahoma City, Oklahoma, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74133
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97201
Providence Heart and Vascular Institute
Portland, Oregon, United States, 97225
United States, Pennsylvania
Saint Luke's Hospital and Health Network
Bethlehem, Pennsylvania, United States, 18018
Holy Spirit Hospital Cardiovascular Institute
Camp Hill, Pennsylvania, United States, 17011
Doylestown Cardiology Associates
Doylestown, Pennsylvania, United States, 18901
Conemaugh Valley Memorial Hospital
Johnstown, Pennsylvania, United States, 15905
Kidney and Hypertension Specialists, PLLC
Manassas, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
V.A. Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Brigham and Women's Cardiovascular Associates at Kent Hospital
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Saint Thomas Hospital
Nashville, Tennessee, United States, 373203
United States, Texas
Texas Heart and Vascular Research
Austin, Texas, United States, 78745
V.A. North Texas Health Care System
Dallas, Texas, United States, 75216
Baylor College of Medicine
Houston, Texas, United States, 77030
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Baylor Research Institute at Legacy Heart Center
Plano, Texas, United States
Audie Murphy V.A.
San Antonio, Texas, United States, 78229
Wichita Falls Heart Clinic
Wichita Falls, Texas, United States
United States, Utah
Salt Lake City V.A. Medical Center
Salt Lake City, Utah, United States
United States, Vermont
White River Junction VAMC
White River Junction, Vermont, United States
United States, Virginia
Cardiovascular Associates, Ltd.
Chesapeake, Virginia, United States, 23320
Valley Health Clinical Research Dept
Winchester, Virginia, United States, 22601
United States, Washington
University of Washington Medical Center
Bellevue, Washington, United States, 98004
United States, Wisconsin
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Hospital Italiano Regional del Sur Bahia Blanca
Bahia Blanca, Buenos Aires, Argentina
Fundacion Favaloro
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1093AAS
Instituto Medico DAMIC
Cordoba, CBA, Argentina, 5009
Clinica Del Prado
Cordoba, Argentina, 5000
Clinica Romagosa and Clinica De La Familia
Cordoba, Argentina, 5000
Clínica Privada Vélez Sarsfield
Cordoba, Argentina
Sanatorio Allende
Cordoba, Argentina
Instituto Cardiovascular San Luis
San Luis, Argentina
Australia, New South Wales
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Austin Health
Heidelberg, Victoria, Australia
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Princess Alexandra Hospital
Woolloongabba, Australia
LKH Graz West Austria
Graz, Stmk, Austria, 8020
University of Vienna Allgemeines Krankenhaus
Vienna, Wien, Austria, 1090
Wilhelminenhospital of Community Vienna
Vienna, Wien, Austria, A-1160
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, Belgium
UZ Leuven/Gasthuisberg University Hospital
Leuven, Brabant, Belgium
Fundacao Bahiana de Cardilogia
Salvador, Bahia, Brazil
Hospital Lifecenter
Belo Horizonte, Minas Gerais, Brazil
Hospital Maternidade e Pronto Socorro Santa Lucia
Pocos de Caldas, Minas Gerais, Brazil
Hospital Cardiologica Costantini
Curitiba, Parana, Brazil
Quanta Diagnostico e Terapia
Curitiba, Parana, Brazil
Hospital Pró-Cardíaco
Botafogo, Rio De Janeiro, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sol
Porto Alegre, Rio Grande Do Sul, Brazil
Instituto de Cardiologia de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Sao Vicente de Paulo
Fundo, RS, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil
Itajai Institute Of Research and Medical Studies (IPEMI)
Itajai, Santa Catarina, Brazil
Instituto Dante Pazzanese de Cardiologia
Ibirapuera, Sao Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirao Preto, Sao Paulo, Brazil
Hospital Totalcor
Sao Paulo, SP, Brazil
Hospital Da Bahia
Salvador, Brazil
Heart Instituto do Coracao - University of Sao Paulo
Sao Paulo, Brazil
Hospital Celso Pierro
Sao Paulo, Brazil
University Federal Hospital of Sao Paulo
Sao Paulo, Brazil
Hucam Ufes
Vitoria, Brazil
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
Canada, British Columbia
Saint Paul's Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Canada, Ontario
West Lincoln Memorial Hospital
Grimsby, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
University Hospital
London, Ontario, Canada
Dixie Medical Group
Mississauga, Ontario, Canada
Dr. James Cha (Private Practice affiliated Lakeridge Helath of Oshawa)
Oshawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Scarborough Cardiology Research
Scarborough, Ontario, Canada
Saint Catharines General Hospital
St. Catharines, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Saint Michael's Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
Northwest GTA Cardiovascular & Heart Rhythm Program
Vaughan, Ontario, Canada
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
Höpital du Sacré-Coeur de Montréal
Montréal, Quebec, Canada
CSSS du Sud de Lanaudiere
Terrebonne, Quebec, Canada
Centre Hospitalier de Regional Trois-Rivieres
Trois-Rivieres, Quebec, Canada
MUHC McGill University Health Center
Montreal, Canada
China, Beijing
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing, China
Fuwai Hospital
Beijing, Beijing, China
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China
China, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
China, Hubei
Tongji Medical College
Wuhan, Hubei, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Wuhan Union Hospital, Tongji Medical College, Huazhong Science and Tech University
Wuhan, Hubei, China
China, Shandong
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Qingdao Fuwai Hospital
Qingdao, Shandong, China
China, Shanxi
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
China, Xinjiang
First Affiliated Hospital of Xinjiang Medical University
Urumqi, Xinjiang, China
Beijing Anzhen Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
TEDA International Cardiovascular Hospital
Tianjing, China
Cairo University Faculty of Medicine
Cairo, Egypt
C.H. Louis Pasteur
Chatres, Centre, France
Ambroise Pare Hospital
Boulogne, Ile De France, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes cedex, Ile De France, France
Bichat Hospital
Paris, Ile-de-France, France
Grenoble University Hospital
Grenoble, Isere, France
Robert Bosch Hospital
Stuttgart, BW, Germany
Universitatsklinikum Bonn
Bonn, NRW, Germany
Praxisklinik Herz Und Gefaesse
Dresden, Saxony, Germany
University of Pecs, Heart Institute
Pecs, Baranya, Hungary
University of Szeged
Szeged, Szeged Megyei Varos, Hungary
George Gottsegen National Institute of Cardiology
Budapest, Hungary
Semmelweis University
Budapest, Hungary
Szent Istvan Hospital
Budapest, Hungary
Gurunanak CARE Hospital
Hyderabad, AP, India
Fortis Escorts Heart Institute
New Delhi, Delhi, India
Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore-Karnataka
Bangalore, Karnataka, India
Medical College Calicut
Calicut, Kerala, India
MOSC Medical College Hospital, Kolenchery
Kolenchery, Kerala, India
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Trivandrum, Kerala, India
KEM Hospital
Pune, Maharashtra, India
Hero DMC Heart Institute Unit Dayanand Medical
Ludhiana, Punjab, India
Apollo Hospitals
Chennai, Tamil Nadu, India
Apollo Health City Campus
Hyderabad, Telangana, India
CARE Hospital
Hyderabad, Telangana, India
King George Medical University
Lucknow, Uttar Pradesh, India
Ram Manohar Lohia Hospital
Delhi, India
Sir Gangaram Hospital
Delhi, India
All India Institute of Medical Sciences
New Delhi, India, 110029
Fortis Healthcare Fl.t Lt. Rajan Dhall Hospital
New Delhi, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry, India
Ruby Hall Clinic
Pune, India
Rambam Medical Center
Haifa, Israel
Assuta Medical Centers
Tel-Aviv, Israel
Policlinico San Marco
Osio Sotto, Bergamo, Italy
Second University of Naples - Monaldi Hospital
Napoli, Campania, Italy
GB Morgagni Hospital-Forli
Forli, Emilia-Romagna, Italy
UOC Cardiologia Ospedale Santo Spirito Roma
Rome, Lazio, Italy
Ospedali Riuniti of Ancona
Ancona, Marche, Italy
Policlinico di Monza
Monza, MB, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, Piemonte, Italy
UO Cardiologia Ospedale SS Cosma e Damiano
Pescia, Pistoia, Italy
Cardiocentro Ticino
Lugano, Ticino, Italy
Ospedale Civile S. Antonio Abate
Tolmezzo, Udine, Italy
University of Padua
Padua, Veneto, Italy
Ospedale Regionale Umberto Parini
Aosta, Italy
Policlinico San Marco
Bergamo, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, Italy
National Cerebral and Cardiovascular Center
Suita-shi, Osaka, Japan
Saitama Medical University
Hidaka, Saitama, Japan
Keio University Hospital
Shinjuka, Tokyo, Japan
Vilnius University Hospital Santariskes Clinic
Vilnius, Lithuania
Benito Juarez, DF, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, Distrito Federal, Mexico
Hospital Central Dr. Ignacio Morones Prieto
SLP, Mexico
Cardio Research Hartcentrum OLVG
Amsterdam, NH, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Isala Klinieken Weezenlanden
Zwolle, Netherlands
New Zealand
Waikato Hospital
Hamilton, Waikato, New Zealand
Auckland City Hospital
Auckland, New Zealand
Instituto Neuro Cardiovascular de las Americas
Mirafloes, Lima, Peru
Polyclinic Independent Public Health Department, 4th Military Clinical Hospital
Wroclaw, Dolny Slask, Poland
Lower Silesia Specialist Hospital T Marciniak
Wrocław, Dolny Śląsk, Poland
Medical University of Lodz
Lodz, Lodzkie, Poland
John Paul II Hospital
Krakow, Maopolskie, Poland
2 nd Department of Coronary Artery Disease
Warsaw, Mazovian, Poland
2 nd Department of Coronary Artery Disease
Warsaw, Mazowieckie, Poland
Coronary and Structural Heart Diseases Department, Institute of Cardiology, Warsaw
Warsaw, Mazowieckie, Poland
Independent Public Central Clinical Hospital, Medical University of Warsaw
Warsaw, Mazowieckie, Poland
Department of Internal Medicine, Infant Jesus Teaching Hospital, Medical University of Warsaw
Warszawa, Mazowieckie, Poland
University Hospital in Bialystok
Bialystok, Podlaskie, Poland
Silesian Center for Heart Diseases
Zabrze, Wojewodztwo Slaskie, Poland
Silesian Center for Heart Disease
Zabrze, Wojewodztwo Slaskie, Poland
University Hospital of the Lord's Transfiguration
Poznan, Poland
John Paul II Hospital
Zamosc, Poland
Hospital Fernando Fonseca
Amadora, Lisboa, Portugal
Hospital de Santa Marta
Lisboa, Portugal
CHLN - Hospital Santa Maria
Lisbon, Portugal
County Emergency Hospital Baia Mare
Baia Mare, Romania
Russian Federation
Bakulev Scientific Center for Cardiovascular Surgery
Moscow, Gorod Moskva, Russian Federation
Academician E.N. Meshalkin Novosibirsk State Research Institute of Circulation Pathology
Novosibirsk, Novosibirskaya Oblast, Russian Federation
North West State Medical University n.a.I.I. Mechnikov
Saint Petersburg, Russian Federation
Almnazov Federal - Heart Blood and Endocrinology Centre
Saint-Petersburg, Russian Federation
Saudi Arabia
King Abdul Aziz Cardiac Center
Riyadh, Central Province, Saudi Arabia
Institute of Cardiovascular Diseases, Vojvodina - Sremska Kamenica
Sremska Kamenica, Vojvodina, Serbia
Cardiology Clinic at Clinical Center of Serbia
Belgrade, Serbia
Cardiovascular Institute Dedinje, Belgrade, Serbia
Belgrade, Serbia
Clinical Center of Serbia
Belgrade, Serbia
University Clinical Hospital Zvezdara
Belgrade, Serbia
University Hospital Center Bezanijska Kosa
Belgrade, Serbia
Clinical Center Kragujevac
Kragujevac, Serbia
Clinic for cardiovascular diseases, Clinical Center Nis
Nis, Serbia
National Heart Centre Singapore
Singapore, Singapore
National University Heart Center
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Complejo Hospitalario Universitario de A Coruna
A Coruna, Spain
Hospital de Bellvitge
Barcelona, Spain
Hospital de Sant Pau Barcelona
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital Clinico de Santiago de Compostela
Santiago de Compostela, Spain
Hospital Universitario y Politecnico La Fe
Valencia, Spain
Danderyds Hospital
Stockholm, Sweden
Uppsala University
Uppsala, Sweden
Mackay Memorial Hospital
Taipei City, Taiwan
Ramathibodi Hospital
Rajthevi, Bangkok, Thailand
Chiang Mai University Hospital
Chiang Mai, Meung, Thailand
United Arab Emirates
SKMC - Sheikh Khalifa Medical City.
Abu Dhabi, United Arab Emirates
United Kingdom
The Belfast Health and Social Care Trust
Belfast, Antrim, United Kingdom
Bedford Hospital NHS Trust
Bedford, Bedfordshire, United Kingdom
Luton and Dunstable Hospital
Luton, Berdfordshire, United Kingdom
Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Peterborough City Hospital
Peterborough, Cambs, United Kingdom
The James Cook University Hospital
Middlesbrough, Cleveland, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom
Dorset County Hospital
Dorchester, Dorset, United Kingdom
The University of Hull/Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom
Broomfield Hospital NHS Trust
Chelmsford, Essex, United Kingdom
Southend University Hospital NHS Trust
Westcliffe On Sea, Essex, United Kingdom
Central Manchester University Hospital
Manchester, Lancashire, United Kingdom
Royal Oldham Hospital
Oldham, Lancashire, United Kingdom
Blackpool Teaching Hospitals
Blackpool, Lancs, United Kingdom
Northwick Park Hospital-Royal Brompton Hospital, London
Harrow, Middlesex, United Kingdom
Ulster Hospital
Belfast, Northern Ireland, United Kingdom
Craigavon Area Hospital
Craigavon, Northern Ireland, United Kingdom
Nottingham University Hospitals
Nottingham, Notts, United Kingdom
South Glasgow Hospitals
Clydebank, Strathclyde, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Edinburgh Heart Centre
Edinburgh, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
King's College Hospital
London, United Kingdom
University College London Hospital
London, United Kingdom
Pinderfields General Hospital
Wakefield, United Kingdom
Sponsors and Collaborators
New York University School of Medicine
New York University
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
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
Study Chair: Judith S Hochman, MD New York University
Principal Investigator: David J Maron, MD Stanford University
  Study Documents (Full-Text)

Documents provided by New York University School of Medicine:
Study Protocol: Study Protocol v.1.0  [PDF] January 18, 2012
Study Protocol: Study Protocol v.2.0  [PDF] January 6, 2014
Study Protocol: Protocol Addendum  [PDF] September 22, 2016

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: New York University School of Medicine Identifier: NCT01471522     History of Changes
Other Study ID Numbers: 11-00498
1U01HL105907 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2011    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

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