Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction
NCT ID: NCT00673842
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
700 participants
INTERVENTIONAL
2011-04-18
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ICD + Usual Care
Implantable Cardioverter Defibrillator + Usual Care
Implantable Cardioverter Defibrillator + Usual Care
Any Medtronic approved single chamber or dual chamber implantable cardioverter defibrillator (ICD)
Usual Care
Usual post-MI care
Usual care
Usual post-MI care
Interventions
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Implantable Cardioverter Defibrillator + Usual Care
Any Medtronic approved single chamber or dual chamber implantable cardioverter defibrillator (ICD)
Usual care
Usual post-MI care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Alberta Innovation and Science
OTHER
Medtronic
INDUSTRY
GE Healthcare
INDUSTRY
Cardiac Arrhythmia Network of Canada
OTHER
Accelerating Clinical Trials Consortium
OTHER
University of Calgary
OTHER
Responsible Party
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Dr. Derek Exner
Professor and Canada Research Chair in Cardiovascular Clinical Trials
Principal Investigators
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Derek V Exner, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Heart Center Research LLC
Huntsville, Alabama, United States
Colorado Heart and Vascular
Lakewood, Colorado, United States
James A Haley Veterans' Center
Tampa, Florida, United States
The Heart Group/Deaconess
Evansville, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Delmarva Heart Foundation
Salisbury, Maryland, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
Washington University Medical School
Saint Louis, Michigan, United States
St. John Providence Hospital
Southfield, Michigan, United States
Lester E Cox Medical Center
Springfield, Missouri, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Associated Cardiovascular Consultants/Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
North Shore LIJ
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Northeast Ohio Cardiovascular Specialists
Akron, Ohio, United States
The Lindner Research Center
Cincinnati, Ohio, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Doylestown Cardiology
Doylestown, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Greenville Hospital System
Greenville, South Carolina, United States
St. Thomas Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Amarillo Heart Group
Amarillo, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Centra Medical Group
Lynchburg, Virginia, United States
Heart Clinics Northwest
Spokane, Washington, United States
UZ Leuven - Campus Gasthuisberg
Leuven, , Belgium
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Fraser Clinical Trials
New Westminster, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital/Providence Health Care
Vancouver, British Columbia, Canada
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Cardio 1
Winnipeg, Manitoba, Canada
New Brunswick Heart Centre
Saint John, New Brunswick, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada
Cambridge Cardiac Care Centre
Cambridge, Ontario, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
University of Western Ontario
London, Ontario, Canada
Southlake
Newmarket, Ontario, Canada
Ottawa Heart Institute
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CHUM
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada
Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)
Trois-Rivières, Quebec, Canada
Prairie Vascular Research Network
Regina, Saskatchewan, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Quebec Heart Institute
Laval, , Canada
HUCH Helsinki University Central Hospital
Helsinki, , Finland
University of Oulu
Oulu, , Finland
CHRU Brest - Hôpital de la Cavale Blanche
Brest, , France
Hôpital Guillaume et René Laënnec - CHU de Nantes
Nantes, , France
Clinique Pasteur
Toulouse, , France
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, , Germany
Zala Megyei Kórház
Zalaegerszeg, , Hungary
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Policlinico Sant' Orsola - Malpighi
Bologna, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Oslo Universitetssykehus Rikshospitalet
Oslo, , Norway
King Saud University
Riyadh, , Saudi Arabia
Slovak Medical University in Bratislava
Bratislava, , Slovakia
Unitas Hospital
Centurion, , South Africa
Hospital General Universitario de Alicante (HGUA)
Alicante, , Spain
Hospital Universitario Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Universitetssjukhuset Örebro
Örebro, , Sweden
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Great Western Hospital NHS Trust
Swindon, , United Kingdom
Countries
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References
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Perkiomaki J, Exner DV, Piira OP, Kavanagh K, Lepojarvi S, Talajic M, Karvonen J, Philippon F, Junttila J, Coutu B, Huikuri H. Heart Rate Turbulence and T-Wave Alternans in Patients with Coronary Artery Disease: The Influence of Diabetes. Ann Noninvasive Electrocardiol. 2015 Sep;20(5):481-7. doi: 10.1111/anec.12244. Epub 2015 Jan 15.
Related Links
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Study Website
Other Identifiers
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21721
Identifier Type: -
Identifier Source: org_study_id
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