REFINE-ICD

Risk Estimation Following Infarction, Non-invasive Evaluation ICD efficacy

Objective

The purpose of this study is to test whether an implantable cardioverter defibrillator (ICD) can improve survival in people who have had a myocardial infarction and have reduced Left Ventricular Ejection Fraction of 36-50%. After a myocardial infarction, some people develop ventricular rhythms. There are changes in the heart’s electrical system that may indicate a higher risk of dangerous heart rhythms and cardiac arrest. The study will identify people who have those specific changes by using a 24-hour Holter test. Participants who have those changes are then randomly assigned to standard medical care or to standard medical care plus an ICD.

  1. Inclusion

    • History of myocardial infarction at least 2 months before enrollment
    • Appropriate post-MI management including revascularization where indicated
    • Indications against ICD placement (e.g., mechanical tricuspid valve, known vascular access problems, active sepsis, etc.)
    • LVEF 36-50% at least 40 days after a confirmed MI or at least 3 months after coronary angioplasty or coronary bypass surgery
    • Patient is on proven, necessary or appropriate medication
    • In normal heart rhythm based on ECG test within 8 weeks prior to enrollment
    • Able and willing to complete the screening 24-hr Holter test including a six-minute walk test

  2. Exclusion

    • Use of antiarrhythmic drugs
    • Clinical indication for permanent pacemaker or a cardiac resynchronization device
    • Clinical indication for an ICD or cardiac resynchronization ICD
    • Prior implantation of a pacemaker, ICD, or Cardiac Resynchronization Device
    • Any condition, in the investigator's judgment, that limits life expectancy to < 12 months
    • Chronic kidney failure (hemodialysis or peritoneal dialysis)
    • Active obstruction to blood flow that is responsive to revascularization if not previously revascularized
    • Participation in another study that may interfere with the REFINE ICD results
    • Pregnancy
    • Inability to comply with the follow-up schedule
Enrolling

Additional Info

Ethics ID: REB15-1328

ClinicalTrials.gov ID: NCT00673842

 

Sponsors: Canadian Institutes of Health Research, Cardiac Arrhythmia Network of Canada (CANet), Alberta Health Services (AHS), Alberta Advanced Education and Technology, Western Economic Diversification and GE Healthcare

 

PI: Dr. Katherine Kavanagh

Phone: 403 210 6152

 

Admin: Wei Qi

Phone: 403 210 7395

E-mail: wqi@ucalgary.ca

Updated Nov 8, 2023

ICF v14