The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches—Chronic Kidney Disease trial (ISCHEMIA-CKD) is an international comparative effectiveness study to determine the best way to manage stable ischemic heart disease (SIHD) in patients with advanced chronic kidney disease (eGFR <30 or on dialysis). Prior trials of strategy trials of revascularization versus medical therapy alone for SIHD have routinely excluded patients with CKD or enrolled a small proportion of such patients. As such, the evidence from randomized trials to drive decision making in this cohort is weak at best.
This is a multicenter clinical trial which has randomized 777 participants with advanced CKD with moderate to severe ischemia on stress testing. Participants were randomly assigned to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization (if feasible) 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.
- Study Design: Randomized controlled trial
- Intervention: Invasive (INV) vs. Conservative (CON).
- Primary Endpoint: Death or myocardial infarction
- Length of Study: 7 years
- Number of Patients Randomized: 777
- Patient Populations: Patients with moderate to severe cardiac ischemia on stress testing and advanced CKD (eGFR < 30 or on dialysis)
For more information on the ISCHEMIA-CKD Ancillary Trial, please visit the ISCHEMIA-CKD Website