REFINE ICD (Risk Estimation Following Infarction Noninvasive Evaluation - ICD efficacy)
Summary
The purpose of this study is to test whether a device called an implantable cardioverter defibrillator (ICD) can improve survival in people who had a heart attack and have reduced pumping function of their heart (Left Ventricular Ejection Fraction of 36-50%). After a heart attack, some people develop dangerous, fast, irregular heart rhythms. It is only poorly understood why. 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 heart monitor test (holter). Participants who have those changes are then randomly assigned to standard medical care or to standard medical care plus an ICD.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 80
Inclusion criteria:
1.) History of heart attack at least 2 months before enrollment
2.) Appropriate post-heart attack management including revascularization where indicated
3.) Indications against ICD placement (e.g., mechanical tricuspid valve, known vascular access problems, active sepsis, etc.)
4.) Measurement of the heart’s pumping function called LVEF (Left Ventricular Ejection Fraction) of 36 to 50%, which was done at least 40 days after a confirmed heart attack or at least 3 months after coronary angioplasty or coronary bypass surgery
5.) Patient is on proven, necessary or appropriate medication
6.) In normal heart rhythm based on Electrocardiogram (ECG) test within 8 weeks prior to enrollment
7.) Able and willing to complete the screening 24-hr heart monitor test (called a Holter) including a six-minute walk test
Exclusion criteria:
1.) Use of drugs to suppress abnormal heart rhythm (antiarrhythmic drugs)
2.) Clinical indication for permanent pacemaker or a cardiac resynchronization device
3.) Clinical indication for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization ICD
4.) Prior implantation of a pacemaker, ICD, or Cardiac Resynchronization Device
5.) Any condition, in the investigator's judgment, that limits life expectancy to < 12 months
6.) Chronic kidney failure (hemodialysis or peritoneal dialysis)
7.) Active obstruction to blood flow that is responsive to revascularization if not previously revascularized
8.) Participation in another study that may interfere with the REFINE ICD results
9.) Pregnancy
10.) Inability to comply with the follow-up schedule
Participate
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Additional information
Contact information
Principal Investigator: Dr. Katherine Kavanagh Study Coordinator: Wei Qi
Principal investigator:
Derek Vincent Exner
Clinical trial:
Yes
REB-ID:
REB14-1912