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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01471522
Registration number
NCT01471522
Ethics application status
Date submitted
10/11/2011
Date registered
15/11/2011
Titles & IDs
Public title
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
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Scientific title
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
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Secondary ID [1]
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1U01HL105907
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Secondary ID [2]
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11-00498
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Universal Trial Number (UTN)
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Trial acronym
ISCHEMIA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases
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Coronary Disease
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Coronary Artery Disease
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Heart Diseases
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Myocardial Ischemia
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0
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Condition category
Condition code
Cardiovascular
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0
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0
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Coronary heart disease
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Cardiovascular
0
0
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0
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Other cardiovascular diseases
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Cardiovascular
0
0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - cardiac catheterization
Treatment: Surgery - coronary artery bypass graft surgery
Treatment: Surgery - percutaneous coronary intervention
BEHAVIORAL - Lifestyle
Treatment: Drugs - Medication
Active comparator: Invasive Strategy (INV) - Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical 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.
Treatment: Surgery: 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.
Treatment: Surgery: 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.
Treatment: Surgery: 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.
BEHAVIORAL: Lifestyle
diet, physical activity, smoking cessation
Treatment: Drugs: Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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BEHAVIORAL
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Intervention code [3]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest
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Assessment method [1]
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Timepoint [1]
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3.2 year follow-up (median)
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Primary outcome [2]
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Cumulative Event Rate of Primary Composite Outcome (Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest)
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Assessment method [2]
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This measure represents the estimated cumulative probability of experiencing the primary endpoint within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur).
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Timepoint [2]
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5 years
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Primary outcome [3]
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Number of Participants That Experienced Death From Cardiovascular Causes or Myocardial Infarction
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Assessment method [3]
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0
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Timepoint [3]
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5 years
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Primary outcome [4]
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Cumulative Event Rate of Death From Cardiovascular Causes or Myocardial Infarction
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Assessment method [4]
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This measure represents the estimated cumulative probability of experiencing Death from cardiovascular causes or myocardial infarction within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur).
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Timepoint [4]
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5 years
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Primary outcome [5]
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Number of Participants That Experienced Death From Any Cause
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Assessment method [5]
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0
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Timepoint [5]
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5 years
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Primary outcome [6]
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Cumulative Event Rate of Death From Any Cause
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Assessment method [6]
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0
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Timepoint [6]
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5 years
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Primary outcome [7]
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Number of Participants That Experienced Myocardial Infarction
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Assessment method [7]
0
0
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Timepoint [7]
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5 years
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Primary outcome [8]
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Cumulative Event Rate of Myocardial Infarction
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Assessment method [8]
0
0
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Timepoint [8]
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5 years
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Primary outcome [9]
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Estimated Difference in Cumulative Event Rate ( %) of Primary Composite Outcome: Invasive Minus Conservative
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Assessment method [9]
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The primary composite outcome includes death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.
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Timepoint [9]
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5 years
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Primary outcome [10]
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Estimated Difference in Cumulative Event Rate of Death From Cardiovascular Causes: Invasive Minus Conservative or Myocardial Infarction Between Invasive and Conservative Strategies
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Assessment method [10]
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0
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Timepoint [10]
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5 years
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Primary outcome [11]
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Estimated Difference in Cumulative Event Rate of Death From Any Cause: Invasive Minus Conservative
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Assessment method [11]
0
0
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Timepoint [11]
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5 years
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Primary outcome [12]
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Estimated Difference in Cumulative Event Rate of Myocardial Infarction: Invasive Minus Conservative
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Assessment method [12]
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0
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Timepoint [12]
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5 years
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Eligibility
Key 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
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/05/2023
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Sample size
Target
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Accrual to date
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Final
5179
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
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Recruitment hospital [1]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [2]
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Flinders Medical Centre - Adelaide
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The Queen Elizabeth Hospital - Woodville South
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2305 - New Lambton Heights
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Recruitment postcode(s) [2]
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5042 - Adelaide
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5011 - Woodville South
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Recruitment postcode(s) [4]
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6000 - Perth
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Recruitment outside Australia
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FG
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Funding & Sponsors
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Name
NYU Langone Health
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New York University
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Stanford University
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National Heart, Lung, and Blood Institute (NHLBI)
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Albany Stratton VA Medical Center
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Cedars-Sinai Medical Center
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Columbia University
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Duke University
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East Carolina University
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Emory University
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Harvard University
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Massachusetts General Hospital
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Montreal Heart Institute
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University of British Columbia
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University of Missouri, Kansas City
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Vanderbilt University
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Ethics approval
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT01471522
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Trial related presentations / publications
Maron DJ, Stone GW, Berman DS, Mancini GB, Scott TA, Byrne DW, Harrell FE Jr, Shaw LJ, Hachamovitch R, Boden WE, Weintraub WS, Spertus JA. Is cardiac catheterization necessary before initial management of patients with stable ischemic heart disease? Results from a Web-based survey of cardiologists. Am Heart J. 2011 Dec;162(6):1034-1043.e13. doi: 10.1016/j.ahj.2011.09.001. Phillips LM, Hachamovitch R, Berman DS, Iskandrian AE, Min JK, Picard MH, Kwong RY, Friedrich MG, Scherrer-Crosbie M, Hayes SW, Sharir T, Gosselin G, Mazzanti M, Senior R, Beanlands R, Smanio P, Goyal A, Al-Mallah M, Reynolds H, Stone GW, Maron DJ, Shaw LJ. Lessons learned from MPI and physiologic testing in randomized trials of stable ischemic heart disease: COURAGE, BARI 2D, FAME, and ISCHEMIA. J Nucl Cardiol. 2013 Dec;20(6):969-75. doi: 10.1007/s12350-013-9773-4. ISCHEMIA Trial Research Group; Maron DJ, Hochman JS, O'Brien SM, Reynolds HR, Boden WE, Stone GW, Bangalore S, Spertus JA, Mark DB, Alexander KP, Shaw L, Berger JS, Ferguson TB Jr, Williams DO, Harrington RA, Rosenberg Y. International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design. Am Heart J. 2018 Jul;201:124-135. doi: 10.1016/j.ahj.2018.04.011. Epub 2018 Apr 21. Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Alexander KP, Senior R, Boden WE, Stone GW, Goodman SG, Lopes RD, Lopez-Sendon J, White HD, Maggioni AP, Shaw LJ, Min JK, Picard MH, Berman DS, Chaitman BR, Mark DB, Spertus JA, Cyr DD, Bhargava B, Ruzyllo W, Wander GS, Chernyavskiy AM, Rosenberg YD, Maron DJ; ISCHEMIA Research Group. Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial. JAMA Cardiol. 2019 Mar 1;4(3):273-286. doi: 10.1001/jamacardio.2019.0014. Erratum In: JAMA Cardiol. 2019 May 1;4(5):497. doi: 10.1001/jamacardio.2019.0866. Reynolds HR, Diaz A, Cyr DD, Shaw LJ, Mancini GBJ, Leipsic J, Budoff MJ, Min JK, Hague CJ, Berman DS, Chaitman BR, Picard MH, Hayes SW, Scherrer-Crosbie M, Kwong RY, Lopes RD, Senior R, Dwivedi SK, Miller TD, Chow BJW, de Silva R, Stone GW, Boden WE, Bangalore S, O'Brien SM, Hochman JS, Maron DJ; ISCHEMIA Research Group. Ischemia With Nonobstructive Coronary Arteries: Insights From the ISCHEMIA Trial. JACC Cardiovasc Imaging. 2023 Jan;16(1):63-74. doi: 10.1016/j.jcmg.2022.06.015. Epub 2022 Sep 14. Garcia RA, Spertus JA, Benton MC, Jones PG, Mark DB, Newman JD, Bangalore S, Boden WE, Stone GW, Reynolds HR, Hochman JS, Maron DJ; ISCHEMIA Research Group. Association of Medication Adherence With Health Outcomes in the ISCHEMIA Trial. J Am Coll Cardiol. 2022 Aug 23;80(8):755-765. doi: 10.1016/j.jacc.2022.05.045. Bangalore S, Spertus JA, Stevens SR, Jones PG, Mancini GBJ, Leipsic J, Reynolds HR, Budoff MJ, Hague CJ, Min JK, Boden WE, O'Brien SM, Harrington RA, Berger JS, Senior R, Peteiro J, Pandit N, Bershtein L, de Belder MA, Szwed H, Doerr R, Monti L, Alfakih K, Hochman JS, Maron DJ; ISCHEMIA Research Group. Outcomes With Intermediate Left Main Disease: Analysis From the ISCHEMIA Trial. Circ Cardiovasc Interv. 2022 Apr;15(4):e010925. doi: 10.1161/CIRCINTERVENTIONS.121.010925. Epub 2022 Apr 12. Mark DB, Spertus JA, Bigelow R, Anderson S, Daniels MR, Anstrom KJ, Baloch KN, Cohen DJ, Held C, Goodman SG, Bangalore S, Cyr D, Reynolds HR, Alexander KP, Rosenberg Y, Stone GW, Maron DJ, Hochman JS; ISCHEMIA Research Group. Comprehensive Quality-of-Life Outcomes With Invasive Versus Conservative Management of Chronic Coronary Disease in ISCHEMIA. Circulation. 2022 Apr 26;145(17):1294-1307. doi: 10.1161/CIRCULATIONAHA.121.057363. Epub 2022 Mar 9. Senior R, Reynolds HR, Min JK, Berman DS, Picard MH, Chaitman BR, Shaw LJ, Page CB, Govindan SC, Lopez-Sendon J, Peteiro J, Wander GS, Drozdz J, Marin-Neto J, Selvanayagam JB, Newman JD, Thuaire C, Christopher J, Jang JJ, Kwong RY, Bangalore S, Stone GW, O'Brien SM, Boden WE, Maron DJ, Hochman JS; ISCHEMIA Research Group. Predictors of Left Main Coronary Artery Disease in the ISCHEMIA Trial. J Am Coll Cardiol. 2022 Feb 22;79(7):651-661. doi: 10.1016/j.jacc.2021.11.052. Newman JD, Anthopolos R, Mancini GBJ, Bangalore S, Reynolds HR, Kunichoff DF, Senior R, Peteiro J, Bhargava B, Garg P, Escobedo J, Doerr R, Mazurek T, Gonzalez-Juanatey J, Gajos G, Briguori C, Cheng H, Vertes A, Mahajan S, Guzman LA, Keltai M, Maggioni AP, Stone GW, Berger JS, Rosenberg YD, Boden WE, Chaitman BR, Fleg JL, Hochman JS, Maron DJ. Outcomes of Participants With Diabetes in the ISCHEMIA Trials. Circulation. 2021 Oct 26;144(17):1380-1395. doi: 10.1161/CIRCULATIONAHA.121.054439. Epub 2021 Sep 15. Lopez-Sendon JL, Cyr DD, Mark DB, Bangalore S, Huang Z, White HD, Alexander KP, Li J, Nair RG, Demkow M, Peteiro J, Wander GS, Demchenko EA, Gamma R, Gadkari M, Poh KK, Nageh T, Stone PH, Keltai M, Sidhu M, Newman JD, Boden WE, Reynolds HR, Chaitman BR, Hochman JS, Maron DJ, O'Brien SM. Effects of initial invasive vs. initial conservative treatment strategies on recurrent and total cardiovascular events in the ISCHEMIA trial. Eur Heart J. 2022 Jan 13;43(2):148-149. doi: 10.1093/eurheartj/ehab509. Reynolds HR, Shaw LJ, Min JK, Page CB, Berman DS, Chaitman BR, Picard MH, Kwong RY, O'Brien SM, Huang Z, Mark DB, Nath RK, Dwivedi SK, Smanio PEP, Stone PH, Held C, Keltai M, Bangalore S, Newman JD, Spertus JA, Stone GW, Maron DJ, Hochman JS. Outcomes in the ISCHEMIA Trial Based on Coronary Artery Disease and Ischemia Severity. Circulation. 2021 Sep 28;144(13):1024-1038. doi: 10.1161/CIRCULATIONAHA.120.049755. Epub 2021 Sep 9. Erratum In: Circulation. 2022 Jun 7;145(23):e1072. doi: 10.1161/CIR.0000000000001080. Circulation. 2022 Jul 5;146(1):e3. doi: 10.1161/CIR.0000000000001084. White HD, O'Brien SM, Alexander KP, Boden WE, Bangalore S, Li J, Manjunath CN, Lopez-Sendon JL, Peteiro J, Gosselin G, Berger JS, Maggioni AP, Reynolds HR, Hochman JS, Maron DJ. Comparison of Days Alive Out of Hospital With Initial Invasive vs Conservative Management: A Prespecified Analysis of the ISCHEMIA Trial. JAMA Cardiol. 2021 Sep 1;6(9):1023-1031. doi: 10.1001/jamacardio.2021.1651. Chaitman BR, Alexander KP, Cyr DD, Berger JS, Reynolds HR, Bangalore S, Boden WE, Lopes RD, Demkow M, Piero Perna G, Riezebos RK, McFalls EO, Banerjee S, Bagai A, Gosselin G, O'Brien SM, Rockhold FW, Waters DD, Thygesen KA, Stone GW, White HD, Maron DJ, Hochman JS; ISCHEMIA Research Group. Myocardial Infarction in the ISCHEMIA Trial: Impact of Different Definitions on Incidence, Prognosis, and Treatment Comparisons. Circulation. 2021 Feb 23;143(8):790-804. doi: 10.1161/CIRCULATIONAHA.120.047987. Epub 2020 Dec 3. Lopes RD, Alexander KP, Stevens SR, Reynolds HR, Stone GW, Pina IL, Rockhold FW, Elghamaz A, Lopez-Sendon JL, Farsky PS, Chernyavskiy AM, Diaz A, Phaneuf D, De Belder MA, Ma YT, Guzman LA, Khouri M, Sionis A, Hausenloy DJ, Doerr R, Selvanayagam JB, Maggioni AP, Hochman JS, Maron DJ. Initial Invasive Versus Conservative Management of Stable Ischemic Heart Disease in Patients With a History of Heart Failure or Left Ventricular Dysfunction: Insights From the ISCHEMIA Trial. Circulation. 2020 Nov 3;142(18):1725-1735. doi: 10.1161/CIRCULATIONAHA.120.050304. Epub 2020 Aug 29. Erratum In: Circulation. 2020 Oct 13;142(15):e236. doi: 10.1161/CIR.0000000000000927. Gala ABE, Curzen N. Is There Still a Place for Revascularisation in the Management of Stable Coronary Artery Disease Following the ISCHEMIA Trial? Heart Int. 2020 Aug 8;14(1):13-15. doi: 10.17925/HI.2020.14.1.13. eCollection 2020. Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30. Spertus JA, Jones PG, Maron DJ, O'Brien SM, Reynolds HR, Rosenberg Y, Stone GW, Harrell FE Jr, Boden WE, Weintraub WS, Baloch K, Mavromatis K, Diaz A, Gosselin G, Newman JD, Mavromichalis S, Alexander KP, Cohen DJ, Bangalore S, Hochman JS, Mark DB; ISCHEMIA Research Group. Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1408-1419. doi: 10.1056/NEJMoa1916370. Epub 2020 Mar 30. Reynolds HR, Shaw LJ, Min JK, Spertus JA, Chaitman BR, Berman DS, Picard MH, Kwong RY, Bairey-Merz CN, Cyr DD, Lopes RD, Lopez-Sendon JL, Held C, Szwed H, Senior R, Gosselin G, Nair RG, Elghamaz A, Bockeria O, Chen J, Chernyavskiy AM, Bhargava B, Newman JD, Hinic SB, Jaroch J, Hoye A, Berger J, Boden WE, O'Brien SM, Maron DJ, Hochman JS; ISCHEMIA Research Group. Association of Sex With Severity of Coronary Artery Disease, Ischemia, and Symptom Burden in Patients With Moderate or Severe Ischemia: Secondary Analysis of the ISCHEMIA Randomized Clinical Trial. JAMA Cardiol. 2020 Jul 1;5(7):773-786. doi: 10.1001/jamacardio.2020.0822. Erratum In: JAMA Cardiol. 2021 Aug 1;6(8):980. doi: 10.1001/jamacardio.2021.1509. Azevedo DFC, Lima EG, Ribeiro MOL, Linhares Filho JPP, Serrano Junior CV. Critical analysis of the classic indications for myocardial revascularization. Rev Assoc Med Bras (1992). 2019 Mar;65(3):319-325. doi: 10.1590/1806-9282.65.3.319. Epub 2019 Apr 11. Shaw LJ, Xie JX, Phillips LM, Goyal A, Reynolds HR, Berman DS, Picard MH, Bhargava B, Devlin G, Chaitman BR. Optimising diagnostic accuracy with the exercise ECG: opportunities for women and men with stable ischaemic heart disease. Heart Asia. 2016 Jun 1;8(2):1-7. doi: 10.1136/heartasia-2016-010736. eCollection 2016. Kataoka A, Scherrer-Crosbie M, Senior R, Gosselin G, Phaneuf D, Guzman G, Perna G, Lara A, Kedev S, Mortara A, El-Hajjar M, Shaw LJ, Reynolds HR, Picard MH. The value of core lab stress echocardiography interpretations: observations from the ISCHEMIA Trial. Cardiovasc Ultrasound. 2015 Dec 18;13:47. doi: 10.1186/s12947-015-0043-2. Stone GW, Hochman JS, Williams DO, Boden WE, Ferguson TB Jr, Harrington RA, Maron DJ. Medical Therapy With Versus Without Revascularization in Stable Patients With Moderate and Severe Ischemia: The Case for Community Equipoise. J Am Coll Cardiol. 2016 Jan 5;67(1):81-99. doi: 10.1016/j.jacc.2015.09.056. Epub 2015 Nov 23. Wasilewski J, Polonski L, Lekston A, Osadnik T, Regula R, Bujak K, Kurek A. Who is eligible for randomized trials? A comparison between the exclusion criteria defined by the ISCHEMIA trial and 3102 real-world patients with stable coronary artery disease undergoing stent implantation in a single cardiology center. Trials. 2015 Sep 15;16:411. doi: 10.1186/s13063-015-0934-4.
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Public notes
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Contacts
Principal investigator
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Judith S Hochman, MD
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New York University
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
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When will data be available (start and end dates)?
June 2022
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What supporting documents are/will be available?
No Supporting Document Provided
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Attachment
Study protocol
Study Protocol: Study Protocol v.1.0
https://cdn.clinicaltrials.gov/large-docs/22/NCT01471522/Prot_000.pdf
Study protocol
Study Protocol: Study Protocol v.2.0
https://cdn.clinicaltrials.gov/large-docs/22/NCT01471522/Prot_001.pdf
Study protocol
Study Protocol: Protocol Addendum
https://cdn.clinicaltrials.gov/large-docs/22/NCT01471522/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/22/NCT01471522/SAP_003.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01471522