Trial Search Results

ISCHEMIA-Chronic Kidney Disease Trial

The purpose of the ISCHEMIA-CKD trial is to determine the best management strategy for patients with stable ischemic heart disease (SIHD), at least moderate ischemia and advanced chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] <30 or on dialysis). This is a multicenter randomized controlled trial with a target randomization of ~1000 patients with advanced CKD and at least moderate ischemia on stress testing. Participants 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. The trial is designed to run seamlessly in parallel to the main ISCHEMIA trial as a companion ancillary trial.


A. Primary Aim. The primary aim of the ISCHEMIA-CKD trial is to determine whether an invasive strategy of routine early catheterization followed by optimal revascularization, in addition to OMT, will reduce the primary composite endpoint of death or nonfatal myocardial infarction in SIHD patients with advanced CKD and at least moderate ischemia over an average follow-up of approximately 4 years compared with an initial conservative strategy of OMT alone with catheterization reserved for those who fail OMT. The primary endpoint is time to centrally adjudicated death or nonfatal myocardial infarction (MI).

B. Secondary Aims. Major: To compare angina-related quality of life between the INV and CON strategies. Other secondary aims include: comparing the incidence of the composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure; composite of cardiovascular death or nonfatal myocardial infarction; cardiovascular death; non-fatal myocardial infarction; all-cause death; stroke; hospitalization for heart failure or unstable angina

Condition: Coronary Disease 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: Columbia University

Stanford Investigator(s):


  • Procedure: Cardiac Catheterization
  • Procedure: Coronary Artery Bypass Graft Surgery
  • Procedure: Percutaneous Coronary Intervention
  • Behavioral: Lifestyle
  • Drug: Medication


Phase 4


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).

   - 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

   - Advanced CKD (eGFR <30 or on dialysis)

Exclusion Criteria:

   - Left Ventricular Ejection Fraction < 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 percutaneous coronary intervention (PCI) or
   coronary artery bypass graft surgery (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

   - New York Heart Association 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

   - Severe valvular disease or valvular disease likely to require surgery 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

   - Pregnancy (known to be pregnant; to be confirmed before randomization, if applicable)

   - Patient who, in the judgment of the patient's physician, is likely to have significant
   unprotected left main stenosis

   - 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 cardiac catheterization at the site

   - 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 at any time, unless coronary anatomy has been demonstrated within the
   previous 12 months to be suitable for PCI or CABG to accomplish complete
   revascularization of ischemic areas.

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study


Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
David Maron