Trial Search Results

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

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 ~5000 patients with at least moderate ischemia on stress testing. Patients are 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.

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 at least moderate 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 Major secondary endpoints include: a) the composite of CV death and nonfatal MI, net clinical benefit (primary and secondary endpoints combined with stroke), angina-related symptoms and disease-specific quality of life, as well as comparing health resource utilization, costs, and cost-effectiveness between groups in North American participants.

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

New York University School of Medicine

Collaborator: Vanderbilt University

Stanford Investigator(s):

Intervention(s):

  • Procedure: cardiac catheterization
  • Procedure: coronary artery bypass graft surgery
  • Procedure: percutaneous coronary intervention
  • Behavioral: Lifestyle
  • Drug: Medication

Phase:

N/A

Eligibility


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)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting