Status:
COMPLETED
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
New York University
Stanford University
Conditions:
Cardiovascular Diseases
Coronary Disease
Eligibility:
All Genders
21+ years
Phase:
NA
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 wit...
Detailed Description
BACKGROUND: Evidence supporting a routine invasive practice paradigm for patients with SIHD is outdated. In strategy trials conducted in the 1970s, coronary artery bypass grafting (CABG) improved sur...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
5179 Patients enrolled
Trial Details
Trial ID
NCT01471522
Start Date
July 1 2012
End Date
May 30 2023
Last Update
June 1 2023
Active Locations (320)
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1
UAB Vascular Biology and Hypertension Program
Birmingham, Alabama, United States, 35294
2
Yuma Regional Medical Center
Yuma, Arizona, United States, 85364
3
Cedars Sinai Medical Center
Beverly Hills, California, United States, 90211
4
UCSF - Fresno Community Regional Medical Center
Fresno, California, United States, 93721