Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction

Last updated: August 15, 2024
Sponsor: University of Calgary
Overall Status: Active - Not Recruiting

Phase

3

Condition

Blood Clots

Heart Defect

Circulation Disorders

Treatment

Implantable Cardioverter Defibrillator + Usual Care

Usual care

Clinical Study ID

NCT00673842
21721
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 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 at least 40 days after a confirmed MI ≥ 3 months after coronary angioplasty or coronary bypass surgery and within the following time windows:

  • LVEF ≤ 7 months of screening visit if index MI was ≤ 1 year of enrolment

  • LVEF ≤ 13 months of screening visit if index MI was > 1 & < 3 years of enrolment

  • LVEF ≤ 25 months of screening visit if index MI was ≥ 3 years of enrolment

  • Proven, necessary or appropriate medications (e.g. beta-blocker, ACE inhibitor / ARB, statin, and anti-platelet)

  • In normal sinus rhythm (ECG documented) ≤ 8 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 at least 2 months after the index MI and the specified time after coronary revascularization

  • In normal sinus rhythm (ECG documented) within 8 weeks prior to the screening Holter

  • In normal sinus rhythm for ≥ 18 hours of the 24 hr screening Holter as determined by the study Holter Core Lab

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 Design

Total Participants: 700
Treatment Group(s): 2
Primary Treatment: Implantable Cardioverter Defibrillator + Usual Care
Phase: 3
Study Start date:
March 01, 2011
Estimated Completion Date:
December 31, 2024

Study Description

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.

Connect with a study center

  • UZ Leuven - Campus Gasthuisberg

    Leuven,
    Belgium

    Site Not Available

  • Libin Cardiovascular Institute of Alberta

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Royal Alexandra Hospital

    Edmonton, Alberta T5H 3V9
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Fraser Clinical Trials

    New Westminster, British Columbia V3L 3W4
    Canada

    Site Not Available

  • St. Paul's Hospital/Providence Health Care

    Vancouver, British Columbia V6E 1M7
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Victoria Cardiac Arrhythmia Trials

    Victoria, British Columbia V8Z 0B9
    Canada

    Site Not Available

  • Cardio 1

    Winnipeg, Manitoba R3L 1Z5
    Canada

    Site Not Available

  • St. Boniface Hospital

    Winnipeg, Manitoba R2H 2A6
    Canada

    Site Not Available

  • New Brunswick Heart Centre

    St. John, New Brunswick E2L 2L4
    Canada

    Site Not Available

  • Memorial University of Newfoundland

    St Johns, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia B3H 3A7
    Canada

    Site Not Available

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario N1R 6V6
    Canada

    Site Not Available

  • Hamilton Health Sciences Centre

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • Hamilton Health Sciences II

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • University of Western Ontario

    London, Ontario N0L 1W0
    Canada

    Site Not Available

  • Southlake

    Newmarket, Ontario L3Y 2P9
    Canada

    Site Not Available

  • Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3N5
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • CHUM

    Montreal, Quebec H2W 1T8
    Canada

    Site Not Available

  • McGill University Health Centre

    Montreal, Quebec H3G 1A4
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montreal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Sherbrooke (CHUS)

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)

    Trois-Rivieres, Quebec G8Z 3R9
    Canada

    Site Not Available

  • Prairie Vascular Research Network

    Regina, Saskatchewan S4P 0W5
    Canada

    Site Not Available

  • Royal University Hospital

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Site Not Available

  • Quebec Heart Institute

    Laval, G1V 4G5
    Canada

    Site Not Available

  • HUCH Helsinki University Central Hospital

    Helsinki,
    Finland

    Site Not Available

  • University of Oulu

    Oulu,
    Finland

    Site Not Available

  • CHRU Brest - Hôpital de la Cavale Blanche

    Brest,
    France

    Site Not Available

  • Hôpital Guillaume et René Laënnec - CHU de Nantes

    Nantes,
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse,
    France

    Site Not Available

  • Universitätsmedizin Göttingen Georg-August-Universität

    Göttingen, 37099
    Germany

    Site Not Available

  • Zala Megyei Kórház

    Zalaegerszeg,
    Hungary

    Site Not Available

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo,
    Italy

    Site Not Available

  • Policlinico Sant' Orsola - Malpighi

    Bologna,
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia,
    Italy

    Site Not Available

  • Oslo Universitetssykehus Rikshospitalet

    Oslo,
    Norway

    Site Not Available

  • King Saud University

    Riyadh,
    Saudi Arabia

    Site Not Available

  • Slovak Medical University in Bratislava

    Bratislava,
    Slovakia

    Site Not Available

  • Unitas Hospital

    Centurion,
    South Africa

    Site Not Available

  • Hospital General Universitario de Alicante (HGUA)

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Universitario Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Universitetssjukhuset Örebro

    Örebro, 70185
    Sweden

    Site Not Available

  • Liverpool Heart and Chest Hospital

    Liverpool,
    United Kingdom

    Site Not Available

  • Great Western Hospital NHS Trust

    Swindon,
    United Kingdom

    Site Not Available

  • Heart Center Research LLC

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Cardiovascular Consultants Heart Center

    Fresno, California 93720
    United States

    Site Not Available

  • Colorado Heart and Vascular

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Watson Clinic

    Lakeland, Florida 33805
    United States

    Site Not Available

  • James A Haley Veterans' Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • The Heart Group/Deaconess

    Evansville, Indiana 47630
    United States

    Site Not Available

  • Iowa Heart Center

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Delmarva Heart Foundation

    Salisbury, Maryland 21804
    United States

    Site Not Available

  • Beth Israel Deaconess

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Washington University Medical School

    Saint Louis, Michigan 63110
    United States

    Site Not Available

  • St. John Providence Hospital

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Lester E Cox Medical Center

    Springfield, Missouri 65807
    United States

    Site Not Available

  • The Valley Hospital

    Ridgewood, New Jersey 07450
    United States

    Site Not Available

  • Associated Cardiovascular Consultants/Lourdes Cardiology Services

    Voorhees, New Jersey 08034
    United States

    Site Not Available

  • New York Presbyterian Hospital

    New York, New York 10032
    United States

    Site Not Available

  • North Shore LIJ

    New York, New York 10029
    United States

    Site Not Available

  • Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Northeast Ohio Cardiovascular Specialists

    Akron, Ohio 44304
    United States

    Site Not Available

  • Bethesda North Hospital

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • The Lindner Research Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Doylestown Cardiology

    Doylestown, Pennsylvania 18901
    United States

    Site Not Available

  • Hamot Medical Center

    Erie, Pennsylvania 16550
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center UPMC Presbyterian

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania 18722
    United States

    Site Not Available

  • South Carolina Heart Center

    Columbia, South Carolina 29204
    United States

    Site Not Available

  • Pee Dee Cardiology

    Florence, South Carolina 29506
    United States

    Site Not Available

  • Greenville Hospital System

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Spartanburg Regional Healthcare System

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • St. Thomas Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Amarillo Heart Group

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Scott & White Healthcare

    Temple, Texas 76508
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Centra Medical Group

    Lynchburg, Virginia 24510
    United States

    Site Not Available

  • Heart Clinics Northwest

    Spokane, Washington 99204
    United States

    Site Not Available

  • Aurora St. Luke's Medical Center/Aurora Cardiovascular Services

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

  • Wheaton Franciscan Healthcare

    Milwaukee, Wisconsin 53210
    United States

    Site Not Available

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