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Study Details

The purpose of the ISCHEMIA-CKD trial is 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 randomized controlled trial with a randomization target of ~700 patients with advanced CKD with moderate to severe ischemia on stress testing. Participants are 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 is designed to run 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: 500-700

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 will prevent 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.

Top 10 Reasons to be part of the ISCHEMIA-CKD Ancillary Trial

  1. It is a simple add-on: ISCHEMIA-CKD mimics the main trial, and uses all of the same systems (InForm, ALMAC, BioClinica), same study flow (with a few exceptions)
  2. There are very few regulatory requirements for participation; site will be paid an administrative fee for processing ISCHEMIA-CKD
  3. It will increase your ability to enroll patients:
    • So far (01/2014), approximately 225 patients have been excluded due to low eGFR in the main trial; participating in ISCHEMIA-CKD provides the opportunity to enroll these patients!
  4. Expectations for randomization are reasonable: only 1-2 patients per year
  5. Risks of contrast exposure are minimized
    • No CCTA required
    • Patients are randomized upstream of the cath lab, therefore 50% of patients have no contrast exposure
      1. No initial contrast exposure: 50% of patients (CON arm)
      2. Some contrast exposure: ~25% of patients (diagnostic cath + CABG)
      3. Contrast exposure: ~25% of patients (diagnostic cath + PCI)
    • If randomized to the INV strategy, contrast minimizing/sparing techniques are used to minimize contrast exposure.  These techniques are outlined in the Optimal Revascularization Therapy Manual of Operations
  6. An NHLBI appointed DSMB will oversee the trial
  7. ISCHEMIA-CKD has a strong renal committee in place to make recommendations that reduce contrast exposure and other risk mitigation  
  8. Unique opportunity to liaise with a nephrologist - increase referrals to your practice and for the trial
  9. You can also enroll patients who are already on dialysis
  10. This is the largest treatment strategy trial in severe CKD patients with stable ischemic heart disease and you can be part of the answer!