Study Details
The purpose of the ISCHEMIA-CKD trial was to determine the best management strategy for patients with moderate to severe cardiac ischemia on stress testing and advanced chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] <30 or on dialysis).
This is a multicenter clinical trial which has randomized 777 patients 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 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 ran seamlessly in parallel to the main ISCHEMIA trial as a companion ancillary 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: 777
Patient Populations: Patients with moderate to severe cardiac ischemia on stress testing and advanced CKD (eGFR < 30 or on dialysis)
Background and Design
Download slides for the background and design of the trial.
Contrast Induced Acute Kidney Injury
Patients with advanced CKD are at higher risk for contrast-induced acute kidney injury. The unique design of the trial, with randomization upstream of cath prevented contrast agent exposure in 50% of randomized patients (those randomized to CON). For patients randomized to INV, measures to minimize the risk of contrast-induced acute kidney injury are outlined in the manual of operations. Utilizing ultra low volume contrast protocols and intravascular ultrasound, -cath and coronary stent placement can be performed with as little as 20-30 cc of contrast.