Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy

Purpose:

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.

Study summary:

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.

Criteria:

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

Study is Available At:

Original ID:

21721

NCT ID:

NCT00673842

Secondary ID:

Study Acronym:

REFINE-ICD

Brief Title:

Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction

Official Title:

Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy

ClinicalTrials.gov Link:

https://clinicaltrials.gov/show/NCT00673842

Overall Status:

Recruiting

Study Phase:

Phase 3

Genders:

Both

Minimum Age:

18 Years

Maximum Age:

80 Years

Study Source:

University of Calgary

Oversight Authority:

Canada: Health Canada

Reasons Why Stopped:

Study Type:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: E

Number of Arms:

2

Number of Groups:

0

Total Enrollment:

1000

Enrollment Type:

Anticipated

Data Source: ClinicalTrials.gov

Date Processed: February 03, 2023

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