Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:6/9/2016
Start Date:March 2011
End Date:December 2021

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Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy

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.

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.

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
We found this trial at
31
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Akron, OH
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Amarillo, Texas 79106
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Boston, Massachusetts 02215
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Cincinnati, Ohio 45219
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Cincinnati, Ohio 45242
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Doylestown, Pennsylvania 18901
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Evansville, Indiana 47630
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Greenville, South Carolina 29615
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Huntsville, Alabama 35801
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Huntsville, Alabama 35801
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Lakewood, Colorado 80228
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Leuven,
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Lynchburg, Virginia 24510
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Nashville, Tennessee 37205
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New York, New York 10029
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New York, New York 10032
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223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
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Saint Louis, Michigan 63110
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Salisbury, Maryland 21804
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Southfield, Michigan 48075
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Spokane, Washington 99204
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Springfield, Missouri
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Tampa, Florida 33612
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West Des Moines, Iowa 50266
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Wilkes-Barre, Pennsylvania 18711
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