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

Use our guide to learn which trials are right for you!

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
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...
?
mi
from
Ridgewood, NJ
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
Amarillo, Texas 79106
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Boston, Massachusetts 02215
?
mi
from
Boston, MA
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
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...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Doylestown, Pennsylvania 18901
?
mi
from
Doylestown, PA
Click here to add this to my saved trials
Evansville, Indiana 47630
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Lakewood, Colorado 80228
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
?
mi
from
Leuven,
Click here to add this to my saved trials
Lynchburg, Virginia 24510
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Nashville, Tennessee 37205
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10032
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Saint Louis, Michigan 63110
?
mi
from
Saint Louis, MI
Click here to add this to my saved trials
Salisbury, Maryland 21804
?
mi
from
Salisbury, MD
Click here to add this to my saved trials
Southfield, Michigan 48075
?
mi
from
Southfield, MI
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Springfield, Missouri
?
mi
from
Springfield, MO
Click here to add this to my saved trials
Tampa, Florida 33612
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
West Des Moines, Iowa 50266
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials
Wilkes-Barre, Pennsylvania 18711
?
mi
from
Wilkes-Barre, PA
Click here to add this to my saved trials