Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01471522
Recruitment Status : Active, not recruiting
First Posted : November 15, 2011
Last Update Posted : October 18, 2019
Sponsor:
Collaborators:
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):
NYU Langone Health

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 8518 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, if feasible, plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cardiac catheterization 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, 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; 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 per NIH

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

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


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

Layout table for study information
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
Actual Primary Completion Date : June 30, 2019
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.


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

Inclusion Criteria:

  • At least moderate ischemia on a qualifying stress 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 ClinicalTrials.gov identifier (NCT number): NCT01471522


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
UAB Vascular Biology and Hypertension Program
Birmingham, Alabama, United States, 35294
United States, Arizona
Yuma Regional Medical Center
Yuma, Arizona, United States, 85364
United States, California
Cedars Sinai Medical Center
Beverly Hills, California, United States, 90211
UCSF - Fresno Community Regional Medical Center
Fresno, California, United States, 93721
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
University of California Irvine Medical Center
Orange, California, United States, 92868
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94087
VA Palo Alto HealthCare System
Palo Alto, California, United States, 94550
Kaiser Permanente San Jose
San Jose, California, United States, 94538
Coastal Heart Medical Group
Santa Ana, California, United States, 92704
Stanford University School of Medicine
Stanford, California, United States, 94305
Torrance Memorial Medical Center
Torrance, California, United States, 90505
United States, Colorado
South Denver Cardiology Associates, P.C.
Littleton, Colorado, United States, 80120
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06111
United States, Florida
Daytona Heart Group
Daytona Beach, Florida, United States, 32114
Malcom Randall VAMC
Gainesville, Florida, United States, 32608
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
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
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
United States, Illinois
Advanced Heart Care Group
Fairview Heights, Illinois, United States, 62208
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, 52803
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Lexington VA Medical Center
Lexington, Kentucky, United States, 42503
University of Louisville
Louisville, Kentucky, United States, 40292
United States, Louisiana
Cardiovascular Specialists of Southwest Louisiana
Lake Charles, Louisiana, United States, 70601
United States, Maryland
University of Maryland Medical Center
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, 20889
United States, Massachusetts
Brigham & Women's Hospital, Harvard Medical School
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
Covenant Medical Center, Inc.
Saginaw, Michigan, United States, 01876
Providence - Providence Park Hospital
Southfield, Michigan, United States, 48075
Michigan Heart, PC
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Minneapolis VAMC
Minneapolis, Minnesota, United States, 55417
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
HealthEast Saint Joseph's Hospital
Saint Paul, Minnesota, United States, 55102
United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States, 08240
Hackensack University Medical Center
Saddle Brook, New Jersey, United States, 07663
United States, New York
Albany Medical Center Hospital
Albany, New York, United States, 12208
Samuel Stratton VA Medical Center of Albany NY
Albany, New York, United States, 12208
Capital Cardiology Associates
Albany, New York, United States, 12211
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 -Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
NYU-HHC Woodhull Hospital
Brooklyn, New York, United States, 11229
Coney Island Hospital
Brooklyn, New York, United States, 11235
NYP Medical Medical Group Hudson Valley Cardiology
Cortlandt Manor, New York, United States, 10567
New York University - Langone Cardiovascular Associates
Flushing, New York, United States, 11355
Mid Valley Cardiology
Kingston, New York, United States, 12401
Northwell Health - Manhasset
Manhasset, New York, United States, 11030
NYU Winthrop
Mineola, New York, United States, 11501
VA New York Harbor Health Care System
New York, New York, United States, 10010
Beth Israel Medical Center
New York, New York, United States, 10016
NYU Langone Medical Center-Bellevue Hospital
New York, New York, United States, 10016
NYU New York Medical Associates
New York, New York, United States, 10022
Mount Sinai Saint Luke's Hospital
New York, New York, United States, 10025
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
Cardiology Associates of Schenectady P.C.
Schenectady, New York, United States, 12309
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
Sanford Health
Fargo, North Dakota, United States, 58122
United States, Ohio
Cincinnati VA Medical Center
Cincinnati, Ohio, United States, 45220
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, United States, 44106
Ohio Health Grant Medical Center
Columbus, Ohio, United States, 43215
United States, Oklahoma
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74133
United States, Oregon
Oregon Health & 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 Health Cardiology
Doylestown, Pennsylvania, United States, 18901
Conemaugh Valley Memorial Hospital
Johnstown, Pennsylvania, United States, 15905
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
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
V.A. North Texas Health Care System
Dallas, Texas, United States, 75216
Baylor College of Medicine
Houston, Texas, United States, 77030
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
Houston Heart & Vascular Associates
Houston, Texas, United States, 77339
Baylor Research Institute at Legacy Heart Center
Plano, Texas, United States, 75024
The Heart Hospital Baylor
Plano, Texas, United States, 75093
Audie Murphy V.A.
San Antonio, Texas, United States, 78229
Medicus Alliance Clinical Research Org., Inc.
Sugar Land, Texas, United States, 77478
Wichita Falls Heart Clinic
Wichita Falls, Texas, United States, 76301
United States, Utah
Salt Lake City VA Medical Center
Salt Lake City, Utah, United States, 84148
United States, Vermont
VAMC-White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
Cardiovascular Associates, Ltd.
Chesapeake, Virginia, United States, 23320
Stroobants Cardiovascular Center
Lynchburg, Virginia, United States, 24501
Winchester Cardiology and Vascular Medicine, PC
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
Argentina
Hospital Italiano Regional del Sur Bahia Blanca
Bahia Blanca, Buenos Aires, Argentina, 8000
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, 5000
Australia, New South Wales
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
Australia, South Australia
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Austria
LKH Graz West Austria
Graz, Stmk, Austria, 8020
Medical University of Vienna, Department of Cardiology
Vienna, Wien, Austria, 1090
Wilhelminen Hospital Vienna
Vienna, Wien, Austria, A-1160
Belgium
University Hospital Leuven
Leuven, Brabant, Belgium, 3000
Brazil
Fundacao Bahiana de Cardilogia
Salvador, Bahia, Brazil, 41810-010
Hospital Lifecenter
Belo Horizonte, Minas Gerais, Brazil, 30110-921
Hospital Maternidade e Pronto Socorro Santa Lucia
Pocos de Caldas, Minas Gerais, Brazil, 37701-045
Quanta Diagnostico & Terapia
Curitiba, Parana, Brazil, 80045-170
Hospital Cardiologico Costantini
Curitiba, Parana, Brazil, 80320-320
Hospital Pró-Cardíaco
Botafogo, Rio De Janeiro, Brazil, 22280-020
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sol
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Instituto de Cardiologia de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90620-001
Hospital Sao Vicente de Paulo
Fundo, RS, Brazil, 99010080
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
Instituto Dante Pazzanese de Cardiologia
Ibirapuera, Sao Paulo, Brazil, 04012-909
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirao Preto, Sao Paulo, Brazil, 14048-900
Hospital TotalCor
Sao Paulo, SP, Brazil, 1418100
Hospital da Bahia
Salvador, Brazil, BA, 41820-011
Unifesp - Hospital Sao Paulo
Sao Paulo, Brazil, 04025-011
Heart Institute (InCor) University of São Paulo
Sao Paulo, Brazil, 05403-000
Hospital Celso Pierro
Sao Paulo, Brazil, 13059-740
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
West Lincoln Memorial Hospital
Grimsby, Ontario, Canada, L3M 1P3
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Dixie Medical Group
Mississauga, Ontario, Canada, L4W 0C2
Dr. James Cha
Oshawa, Ontario, Canada, L1J 2K1
Scarborough Cardiology Research
Scarborough, Ontario, Canada, M1E 5E9
Saint Catharines General Hospital
St. Catharines, Ontario, Canada, L2S0A9
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Women's College Hospital
Toronto, Ontario, Canada, M5G 1N8
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Northwest GTA Cardiovascular and Heart Rhythm Program
Vaughan, Ontario, Canada, L4H0P6
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Centre Intégré Universitaire de Santé et de Services Sociaux du Montréal
Montréal, Quebec, Canada, H4J 1C5
CISSSL - Hopital Pierre-Le Gardeur
Terrebonne, Quebec, Canada, J6V 2H2
Centre Hospitalier de Regional Trois-Rivieres
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Canada
University of Ottawa Heart Institute
Ottawa, Canada, K1Y 4W7
China, Beijing
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing, China, 100020
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing, China, 100037
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
China, Chaoyang
Beijing Anzhen Hospital
Beijing, Chaoyang, China, 100029
China, Fangshan
Liangxiang Hospital, Beijing Fangshan District
Beijing, Fangshan, China, 102401
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510100
China, Hebei
Tangshan Gongren Hospital
Tangshan, Hebei, China, 063000
China, Henan
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450014
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
China, Hubei
Tongji Medical College
Wuhan, Hubei, China, 430030
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Wuhan Union Hospital, Tongji Medical College, Huazhong Science and Tech University
Wuhan, Hubei, China
China, Liaoning
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China, 116001
China, Shandong
Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272000
Qingdao Fuwai Hospital
Qingdao, Shandong, China, 266071
China, Shanxi
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China, 030024
Shanxi Provincial People's Hospital
Xian, Shanxi, China, 710000
China, Tianjing
TEDA International Cardiovascular Hospital
Tianjing, Tianjing, China, 300457
China, Xinjiang
First Affiliated Hospital of Xinjiang Medical University
Urumqi, Xinjiang, China, 830054
China, Zhejiang
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Egypt
Cairo University
Cairo, Egypt, 11562
France
C.H. Louis Pasteur
Chatres, Centre, France, 28018
Ambroise Pare Hospital
Boulogne, Ile De France, France, 92100
Centre Hospitalier Sud Francilien
Corbeil-Essonnes cedex, Ile De France, France, 91100
Antoine-Beclere Hospital
Clamart Cedex, Ile-de-France, France, 92141
Bichat Hospital
Paris, Ile-de-France, France, 75018
Grenoble University Hospital
Grenoble, Isere, France, 38700
Centre Hospitalier Universitaire d'Angers
Angers Cedex 9, Pays De La Loire, France, 49933
Germany
Robert-Bosch-Krankenhaus
Stuttgart, BW, Germany, 70376
Universitatsklinikum Bonn
Bonn, NRW, Germany, 53105
Praxisklinik Herz Und Gefaesse
Dresden, Saxony, Germany, D-01099
University Hospital Jena
Jena, Thuringia, Germany, 07747
Hungary
University of Szeged
Szeged, Szeged Megyei Varos, Hungary, 6720
Eszszk- Szent Istvan Hospital
Budapest, Hungary, 1097
Military Hospital, Budapest
Budapest, Hungary, 1117
Heart and Vascular Center, Semmelweis University
Budapest, Hungary, 1122
George Gottsegen National Institute of Cardiology
Budapest, Hungary, H-1096
India
CARE Hospital
Hyderabad, Andhra Pradesh, India, 500034
Gurunanak CARE Hospital
Hyderabad, AP, India, 500020
Dr Ram Manohar Lohia Hospital
New Delhi, Delhi, India, 110001
Fortis Escort Heart Institute
New Delhi, Delhi, India, 110025
Batra Hospital and Medical Research Centre (BHMRC)
New Delhi, Delhi, India, 110062
Fortis Healthcare Fl.t Lt. Rajan Dhall Hospital
New Delhi, Delhi, India, 110070
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Bangalore, Karnataka, India, 560069
Government Medical College
Calicut, Kerala, India, 673008
MOSC Medical College Hospital, Kolenchery
Kolenchery, Kerala, India, 682311
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Trivandrum, Kerala, India, 695011
Ruby Hall Clinic,Grant Medical Foundation
Pune, Maharashtra, India, 411001
KEM Hospital Pune
Pune, Maharashtra, India, 411011
Hero DMC Heart Institute, Dayanand Medical College and Hospital
Ludhiana, Punjab, India, 141001
Apollo Research and Innovation
Chennai, Tamil Nadu, India, 600081
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)
Pondicherry, Tamil Nadu, India, 605006
CARE Nampally
Hyderabad, Telangana, India, 500001
Apollo Research & Innovations
Hyderabad, Telangana, India, 600081
King George's Medical University, Department of Cardiology
Lucknow, Uttar Pradesh, India, 226003
All India Institute of Medical Sciences
New Delhi, India, 110029
Israel
Rambam Medical Center
Haifa, Israel, 31096
Assuta Medical Centers
Tel-Aviv, Israel, 67891
Italy
AORN Dei Colli "V. Monaldi" UOC Cardiologia Università della Campania "L.Vanvitelli"
Napoli, Campania, Italy, 80131
Ospedale "G.B. Morgagni - L. Pierantoni" Forli (AUSL della Romagna)
Forli, Emilia-Romagna, Italy, 47100
IRCCS "Casa Sollievo della Sofferenza"
San Giovanni Rotondo, FG, Italy, 71013
Cardiology and CCU - Ospedali Riuniti Ancona
Ancona, Marche, Italy, 60020
Policlinico di Monza, Monza MB
Monza, MB, Italy, 20900
Humanitas Research Hospital, Rozzano (MI)
Rozzano, Milano, Italy, 20089
Azienda Ospedaliera S. Croce e Carle
Cuneo, Piemonte, Italy, 12100
UO Cardiologia Ospedale SS Cosma e Damiano
Pescia, Tuscany, Italy, 54100
Azienda Servizi Sanitaria n.3 Alto Friuli-Collinare-Medio Friuli
Tolmezzo, Udine, Italy, 33028
University of Padua- Cardiology Clinic
Padua, Veneto, Italy, 35100
Ospedale Regionale Umberto Parini
Aosta, Italy, 11100
Clinica Mediterranea
Naples, Italy, 80121
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Japan
National Cerebral and Cardiovascular Center
Suita-shi, Osaka, Japan, 565-8565
Saitama Medical University
Hidaka, Saitama, Japan, 350-0495
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan, 160-8582
Lithuania
Vilnius University Hospital Santariskes Clinic
Vilnius, Lithuania, LT-08661
Malaysia
Institut Jantung Negara
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50400
Mexico
Instituto Mexicano del Seguro Social
Benito Juarez, DF, Mexico, 3100
Instituto Nacional de Cardiología "Ignacio Chávez"
Mexico City, Distrito Federal, Mexico, 14080
Netherlands
Cardio Research Hartcentrum OLVG
Amsterdam, NH, Netherlands, 1091 AC
Radboudumc
Nijmegen, Netherlands, 6500 HB
Isala Klinieken
Zwolle, Netherlands, 8025 AB
New Zealand
Waikato Hospital
Hamilton, Waikato, New Zealand, 3240
Auckland City Hospital
Auckland, New Zealand, 1142
North Macedonia
University Clinic of Cardiology
Skopje, Republic Of Macedo, North Macedonia, 1000
Peru
Instituto Neuro Cardiovascular De Las Americas
Mirafloes, Lima, Peru, 18
Poland
T.Marciniak Hospital
Wrocław, Dolny Śląsk, Poland, 54-090
Cardiology Clinic, Medical University in Lodz
Lodz, Lodzkie, Poland, 91-425
Department of Coronary Disease, John Paul II Hospital, Jagiellonian University Medical College
Krakow, Maopolskie, Poland, 31-200
Institute of Cardiology, Warsaw
Warsaw, Mazovian, Poland, 04-628
Coronary and Structural Heart Diseases Department, Institute of Cardiology
Warsaw, Mazowieckie, Poland, 04-628
Department of Interventional Cardiology & Angiology, Institute of Cardiology
Warsaw, Mazowieckie, Poland, 04-628
Medical University of Warsaw
Warsaw, Mazowieckie, Poland, PL-02-097
Department of Internal Medicine and Cardiology, Infant Jesus Teaching Hospital, Medical University of Warsaw
Warszawa, Mazowieckie, Poland, 02-005
University Hospital in Bialystok
Bialystok, Podlaskie, Poland, 15-276
Medical University of Silesia, School of Medicine with the Division of Dentistry, Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Silesian Center for Heart Diseases
Zabrze, Wojewodztwo Slaskie, Poland, 41-800
Szpital Kliniczny Przemienienia Pańskiego
Poznan, Poland, 61-848
Military Hospital / Medical University
Wroclaw, Poland, 50-981
Portugal
Hospital de Santa Marta
Lisboa, Portugal, 1150-291
Santa Maria University Hospital, Cardiology Department, CHLN
Lisbon, Portugal, 1649-028
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
Vila Nova de Gaia, Portugal, 4434-502
Romania
Emergency County Hospital Baia Mare
Baia Mare, Romania, 021967
Emergency Institute of Cardiovascular Diseases ''Prof. Dr. C. C. Iliescu''
Bucharest, Romania, 022328
Russian Federation
National Medical Research Center for Cardiovascuar Surgery
Moscow, Gorod Moskva, Russian Federation, 121552
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630055
North-Western State Medical University
Saint Petersburg, Russian Federation, 199106
Federal Almazov North-West Medical Research Centre
Saint-Petersburg, Russian Federation, 197341
Saudi Arabia
King AbdulAziz Cardiac Center
Riyadh, Central Province, Saudi Arabia, 11426
Serbia
Institute of Cardiovascular Diseases Vojvodina, Sremska Kamenica, Serbia and Faculty of Medicine, University of Novi Sad
Sremska Kamenica, Vojvodina, Serbia, 21204
Clinical Center of Serbia
Belgrade, Serbia, 11000
Faculty of Medicine, University of Belgrade; Cardiology Clinic, Clinical Center of Serbia
Belgrade, Serbia, 11000
University Clinical Hospital Zvezdara
Belgrade, Serbia, 11000
University Hospital Center Bezanijska Kosa
Belgrade, Serbia, 11000
Clinical Center Kragujevac
Kragujevac, Serbia, 11000
Clinic for Cardiovascular Diseases, Clinical Center Nis
Nis, Serbia, 18000
Singapore
National University Heart Center Singapore
Singapore, Singapore, 119228
National Heart Centre Singapore
Singapore, Singapore, 169609
Tan Tock Seng Hospital
Singapore, Singapore, 308433
South Africa
Groote Schuur Hospital / University of Cape Town
Cape Town, Western Cape, South Africa, 7945
Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, La Coruna, Spain, 15706
Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas, Department of Cardiology. INIBIC A Coruña. CIBER-CV. Universidad de A Coruña, Spain
A Coruna, Spain, 15008
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital De Bellvitge
Barcelona, Spain, 08907
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Hospital La Paz. IdiPaz
Madrid, Spain, 28046
HUVA, Hospital Clínico Universitario Virgen De La Arrixaca
Murcia, Spain, 30120
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sweden
Karolinska Institutet at Danderyd Hospital
Stockholm, Sweden, S-18288
Uppsala University
Uppsala, Sweden, SE-751 85
Switzerland
Cardiocentro
Lugano, Ticino, Switzerland, 6900
Taiwan
Mackay Memorial Hospital
Taipei City, Taiwan, 10449
Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Meung, Thailand, 50200
Ramathibodi Hospital
Bangkok, Thailand, 10400
United Kingdom
Belfast Trust
Belfast, Antrim, United Kingdom, BT12 6BA
Bedford Hospital NHS Trust
Bedford, Bedfordshire, United Kingdom, MK42 9DJ
Luton and Dunstable University Hospital NHS FT
Luton, Berdfordshire, United Kingdom, LU4 0DZ
Papworth Hospital
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Peterborough City Hospital
Peterborough, Cambs, United Kingdom, PE3 9GZ
The James Cook University Hospital, Middlesbrough
Middlesbrough, Cleveland, United Kingdom, TS4 3BW
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Dorset County Hospital
Dorchester, Dorset, United Kingdom, DT1 2JY
The University of Hull/Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Broomfield Hospital
Chelmsford, Essex, United Kingdom, CM1 7ET
Southend University Hospital
Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom, RG24 9NA
Blackpool Teaching Hospitals
Blackpool, Lancashire, United Kingdom, FY3 8NR
The Pennine Acute Hospitals NHS Trust
Oldham, Lancashire, United Kingdom, OL1 2JH
Northwick Park Hospital Harrow/ Royal Brompton Hospital London
Harrow, Middlesex, United Kingdom, HA1 3UJ
South Eastern Health and Social Care
Belfast, Northern Ireland, United Kingdom, BT16 1RH
Cardiovascular Research Unit, Craigavon Area Hospital
Craigavon, Northern Ireland, United Kingdom, BT63 5QQ
Nottingham University Hospitals
Nottingham, Notts, United Kingdom, NG5 1PB
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH4 2XU
University of Glasgow
Clydebank, Strathclyde, United Kingdom, G81 4DY
Russells Hall Hospital
Dudley, West Midlands, United Kingdom, DY1 2HQ
Bradford Royal Infirmary
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
Pinderfields Hospital
Wakefield, West Yorkshire, United Kingdom, WF1 4DG
University College London Hospitals NHS Foundation Trust/Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
King's College NHS Foundation Hospital
London, United Kingdom, SE13 6LH
Imperial College Healthcare NHS Trust
London, United Kingdom, W12OHS
Central Manchester University Hospital
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
NYU Langone Health
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
Investigators
Layout table for investigator information
Study Chair: Judith S Hochman, MD New York University
Principal Investigator: David J Maron, MD Stanford University
  Study Documents (Full-Text)

Documents provided by NYU Langone Health:
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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov 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: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be submitted to the NHLBI according to their guidelines within 3 years after the final patient follow-up (June 30, 2019) or 2 years after the main paper of the trial has been published, whichever comes first.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: June 2022
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes