International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
This study is currently recruiting participants.
Verified May 2013 by New York University School of Medicine
Sponsor:
New York University School of Medicine
Collaborators:
New York University
Vanderbilt University
Albany Stratton VA Medical Center
East Carolina University
Duke University
Harvard University
University of Missouri, Kansas City
Emory University
Cedars-Sinai Medical Center
Massachusetts General Hospital
University of Calgary
Columbia University
University of British Columbia
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01471522
First received: November 10, 2011
Last updated: May 22, 2013
Last verified: May 2013
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Purpose
The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~8000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT.
SPECIFIC AIMS
A. Primary Aim The primary aim of the ISCHEMIA trial is to test the hypothesis that in patients with moderate or severe ischemia on stress imaging, a routine invasive strategy with cath followed by revascularization plus OMT is superior to a conservative strategy of OMT, with cath and revascularization reserved for those with an acute ischemic event or refractory symptoms. The primary endpoint is time to centrally adjudicated cardiovascular death or nonfatal myocardial infarction.
B. Secondary Aims Major: To test the hypothesis that INV improves angina-related quality of life. Other secondary aims include: a) comparing the incidence of all-cause death; the components of the primary endpoint; the composite endpoint of cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure; stroke; and stroke combined with cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure between randomized groups; and b) comparing health resource utilization, costs, and cost-effectiveness between groups.
Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III
Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III
Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III
| Condition | Intervention |
|---|---|
|
Cardiovascular Diseases Coronary Disease Coronary Artery Disease Heart Diseases Myocardial Ischemia |
Procedure: cardiac catheterization Procedure: coronary artery bypass graft surgery Procedure: percutaneous coronary intervention Behavioral: Lifestyle Drug: Medication |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) |
Resource links provided by NLM:
MedlinePlus related topics:
Angina
Cardiac Arrest
Coronary Artery Bypass Surgery
Coronary Artery Disease
Heart Attack
Heart Diseases
Heart Failure
U.S. FDA Resources
Further study details as provided by New York University School of Medicine:
Primary Outcome Measures:
- Time to first occurrence of cardiovascular death or nonfatal myocardial infarction. [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Angina control per Seattle Angina Questionnaire (SAQ) Angina Frequency Scale [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
- Disease specific quality of life per Seattle Angina Questionnaire (SAQ) Quality of Life Scale [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
- Composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
- Cardiovascular death [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
- Nonfatal myocardial infarction [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
- Resuscitated cardiac arrest [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
- Hospitalization for unstable angina [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
- Hospitalization for heart failure [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
- Stroke [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
- Composite of cardiovascular death, nonfatal myocardial infarction, stroke, resuscitated cardiac arrest, hospitalization for unstable angina or heart failure. [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
- Health resource utilization, costs, and cost effectiveness [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 8000 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | May 2019 |
| Estimated Primary Completion Date: | May 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Invasive Strategy (INV)
Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy.
|
Procedure: cardiac catheterization
Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization.
Other Name: cath
Procedure: coronary artery bypass graft surgery
Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, "cabbage"). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart.
Other Name: CABG
Procedure: percutaneous coronary intervention
Percutaneous coronary intervention may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.
Other Name: PCI
Behavioral: Lifestyle
diet, physical activity, smoking cessation
Other Name: Behavior change
Drug: Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Other Name: Pharmacologic Therapy
|
|
Active Comparator: Conservative Strategy
Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms.
|
Behavioral: Lifestyle
diet, physical activity, smoking cessation
Other Name: Behavior change
Drug: Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Other Name: Pharmacologic Therapy
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- At least moderate ischemia on a stress imaging test with nuclear myocardial perfusion (≥10% myocardium), echo or cardiac magnetic resonance wall motion (≥3/16 segments with stress-induced severe hypokinesis or akinesis), or cardiac magnetic resonance perfusion (≥12% myocardium).
- 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
- Prior known 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 or CABG within the previous 12 months
- Stroke within the previous 6 months or intracranial hemorrhage at any time
- History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia
- 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
- Severe valvular disease or valvular disease likely to require surgery within 5 years
- 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
- Life expectancy less than 5 years due to non-cardiovascular comorbidity
- Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable)
- 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 limits for CCTA or cardiac catheterization at the enrolling site
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471522
Contacts
| Contact: Judith S Hochman, MD | 212-263-4225 | ISCHEMIA@nyumc.org |
| Contact: Jeannie Denaro | 212-263-4225 | ISCHEMIA@nyumc.org |
Locations
| United States, New York | |
| New York University School of Medicine | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Harmony R Reynolds, MD 212-263-4225 ISCHEMIA@nyumc.org | |
| Principal Investigator: Harmony R Reynolds, MD | |
Sponsors and Collaborators
New York University School of Medicine
New York University
Vanderbilt University
Albany Stratton VA Medical Center
East Carolina University
Duke University
Harvard University
University of Missouri, Kansas City
Emory University
Cedars-Sinai Medical Center
Massachusetts General Hospital
University of Calgary
Columbia University
University of British Columbia
Investigators
| Study Chair: | Judith S Hochman, MD | New York University |
| Principal Investigator: | David J Maron, MD | Vanderbilt University |
More Information
Additional Information:
Publications:
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01471522 History of Changes |
| Other Study ID Numbers: | 713, 1U01HL105907 |
| Study First Received: | November 10, 2011 |
| Last Updated: | May 22, 2013 |
| Health Authority: | United States: Data and Safety Monitoring Board United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Ischemia Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013