Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction

Study Overview
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Brief Summary
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This study will assess whether an implantable defibrillator will increase the likelihood of survival in patients who have had a heart attack in the prior 5 years, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.

Detailed Description
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The REFINE ICD trial will assess whether prophylactic ICD therapy, guided by non-invasive risk assessment tools, reduces mortality in MI survivors with better-preserved LV function.

Official Title
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Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy

Conditions
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Sudden Death, Myocardial Infarction

Intervention / Treatment
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* Device: Implantable Cardioverter Defibrillator + Usual Care
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Site investigators are responsible for screening. Subjects must meet all inclusion criteria. Subjects with any exclusion criteria will be excluded. Initial inclusion criteria (eligibility for Holter screening). 18 - 80 years old at time of consent History of MI > / = 2 and < / = 60 months prior to screening based on ESC/ACCF/AHA/WHF criteria (both STEMI and NSTEMI subjects are eligible) Appropriate post-MI management including revascularization where indicated No contra-indication for transvenous ICD placement (e.g., mechanical tricuspid valve, known vascular access problems, active sepsis, etc.) LVEF 36% - 50% measured 2 to 60 months after a confirmed MI, > / = 3 months after coronary angioplasty or coronary bypass surgery and < / = 6 months of the screening visit Proven, necessary or appropriate medications (e.g. beta-blocker, ACE inhibitor / ARB, statin, and anti-platelet) In normal sinus rhythm (ECG documented) within the two weeks prior to the screening Holter Written informed consent Able and willing to complete the screening Holter, including the six-minute hall walk Additional inclusion criterion (eligibility for randomization). • Abnormal HRT & TWA (core lab interpretation) on Holter performed 2 to 60 months after the index MI and the specified time after coronary revascularization Exclusion criteria (randomization or registry). 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 would limit life expectancy to < 12 months Chronic renal failure (hemodialysis or peritoneal dialysis) Active ischemia that is amenable to revascularization if not previously revascularized Participation in another trial that may interfere with the REFINE ICD results. Pregnancy Inability to comply with the follow-up schedule

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantable Cardioverter Defibrillator + Usual Care<br>Medtronic ICD | Device: Implantable Cardioverter Defibrillator + Usual Care<br>* Any Medtronic approved (in each geography) single chamber or dual chamber implantable cardioverter defibrillator (ICD)<br>* Other names: ICD;|
| Active Comparator: Usual Care<br>Usual post-MI care | Other: Usual care<br>* Usual post-MI care<br>* Other names: Standard medical therapy alone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Minimum of 18 months of follow-up (average follow-up of 5 years). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death |  | Average follow-up 5 years. | 
| Arrhythmic death |  | Average follow-up 5 years. | 
| Arrhythmic syncope |  | Average follow-up 5 years. | 
| Appropriate ICD therapies |  | Average follow-up 5 years. | 
| Quality of life |  | Average follow-up 5 years. | 
| Inappropriate ICD therapies |  | Five years (average) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Noninvasive assessment, Holter