Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction
- Conditions
- Myocardial InfarctionSudden Death
- Interventions
- Other: Usual careDevice: Implantable Cardioverter Defibrillator + Usual Care
- Registration Number
- NCT00673842
- Lead Sponsor
- University of Calgary
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 700
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Usual care Usual post-MI care Implantable Cardioverter Defibrillator + Usual Care Implantable Cardioverter Defibrillator + Usual Care Medtronic ICD
- Primary Outcome Measures
Name Time Method Mortality Minimum of 18 months of follow-up (average follow-up of 5 years).
- Secondary Outcome Measures
Name Time Method Inappropriate ICD therapies Five years (average) Arrhythmic syncope Average follow-up 5 years. Quality of life Average follow-up 5 years. Appropriate ICD therapies Average follow-up 5 years. Cardiac death Average follow-up 5 years. Arrhythmic death Average follow-up 5 years.
Trial Locations
- Locations (78)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Beth Israel Deaconess
🇺🇸Boston, Massachusetts, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Doylestown Cardiology
🇺🇸Doylestown, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
Cardio 1
🇨🇦Winnipeg, Manitoba, Canada
St. Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada
New York Presbyterian Hospital
🇺🇸New York, New York, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Fraser Clinical Trials
🇨🇦New Westminster, British Columbia, Canada
UZ Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Libin Cardiovascular Institute of Alberta
🇨🇦Calgary, Alberta, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
HUCH Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)
🇨🇦Trois-Rivieres, Quebec, Canada
University of Oulu
🇫🇮Oulu, Finland
Queen Elizabeth II Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Associated Cardiovascular Consultants/Lourdes Cardiology Services
🇺🇸Voorhees, New Jersey, United States
Oslo Universitetssykehus Rikshospitalet
🇳🇴Oslo, Norway
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
🇨🇦Sherbrooke, Quebec, Canada
Centra Medical Group
🇺🇸Lynchburg, Virginia, United States
Heart Clinics Northwest
🇺🇸Spokane, Washington, United States
Victoria Cardiac Arrhythmia Trials
🇨🇦Victoria, British Columbia, Canada
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Amarillo Heart Group
🇺🇸Amarillo, Texas, United States
James A Haley Veterans' Center
🇺🇸Tampa, Florida, United States
St. Thomas Research Institute
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Heart Center Research LLC
🇺🇸Huntsville, Alabama, United States
The Heart Group/Deaconess
🇺🇸Evansville, Indiana, United States
Colorado Heart and Vascular
🇺🇸Lakewood, Colorado, United States
St. John Providence Hospital
🇺🇸Southfield, Michigan, United States
Lester E Cox Medical Center
🇺🇸Springfield, Missouri, United States
Delmarva Heart Foundation
🇺🇸Salisbury, Maryland, United States
Washington University Medical School
🇺🇸Saint Louis, Michigan, United States
Northeast Ohio Cardiovascular Specialists
🇺🇸Akron, Ohio, United States
North Shore LIJ
🇺🇸New York, New York, United States
The Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
University of Pittsburgh Medical Center UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
New Brunswick Heart Centre
🇨🇦St. John, New Brunswick, Canada
Cambridge Cardiac Care Centre
🇨🇦Cambridge, Ontario, Canada
Hamilton Health Sciences Centre
🇨🇦Hamilton, Ontario, Canada
Southlake
🇨🇦Newmarket, Ontario, Canada
University of Western Ontario
🇨🇦London, 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
CHUM
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Quebec Heart Institute
🇨🇦Laval, Canada
Hôpital Guillaume et René Laënnec - CHU de Nantes
🇫🇷Nantes, France
CHRU Brest - Hôpital de la Cavale Blanche
🇫🇷Brest, France
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Universitätsmedizin Göttingen Georg-August-Universität
🇩🇪Göttingen, Germany
Clinique Pasteur
🇫🇷Toulouse, France
Zala Megyei Kórház
🇭🇺Zalaegerszeg, Hungary
Policlinico Sant' Orsola - Malpighi
🇮🇹Bologna, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Slovak Medical University in Bratislava
🇸🇰Bratislava, Slovakia
King Saud University
🇸🇦Riyadh, Saudi Arabia
Unitas Hospital
🇿🇦Centurion, South Africa
Hospital Universitario Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital General Universitario de Alicante (HGUA)
🇪🇸Alicante, Spain
Liverpool Heart and Chest Hospital
🇬🇧Liverpool, United Kingdom
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Great Western Hospital NHS Trust
🇬🇧Swindon, United Kingdom
Prairie Vascular Research Network
🇨🇦Regina, Saskatchewan, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital/Providence Health Care
🇨🇦Vancouver, British Columbia, Canada
Universitetssjukhuset Örebro
🇸🇪Örebro, Sweden