Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction
REFINE-ICD
Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy
1 other identifier
interventional
700
15 countries
79
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2011
Longer than P75 for phase_3
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2008
CompletedFirst Posted
Study publicly available on registry
May 7, 2008
CompletedStudy Start
First participant enrolled
April 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedMay 30, 2025
May 1, 2025
13.5 years
April 29, 2008
May 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Minimum of 18 months of follow-up (average follow-up of 5 years).
Secondary Outcomes (6)
Cardiac death
Average follow-up 5 years.
Arrhythmic death
Average follow-up 5 years.
Arrhythmic syncope
Average follow-up 5 years.
Appropriate ICD therapies
Average follow-up 5 years.
Quality of life
Average follow-up 5 years.
- +1 more secondary outcomes
Study Arms (2)
ICD + Usual Care
EXPERIMENTALImplantable Cardioverter Defibrillator + Usual Care
Usual Care
ACTIVE COMPARATORUsual post-MI care
Interventions
Any Medtronic approved single chamber or dual chamber implantable cardioverter defibrillator (ICD)
Eligibility Criteria
You may not qualify if:
- 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
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Canadian Institutes of Health Research (CIHR)collaborator
- Alberta Innovation and Sciencecollaborator
- Medtroniccollaborator
- GE Healthcarecollaborator
- Cardiac Arrhythmia Network of Canadacollaborator
- Accelerating Clinical Trials Consortiumcollaborator
Study Sites (79)
Heart Center Research LLC
Huntsville, Alabama, 35801, United States
Colorado Heart and Vascular
Lakewood, Colorado, 80228, United States
James A Haley Veterans' Center
Tampa, Florida, 33612, United States
The Heart Group/Deaconess
Evansville, Indiana, 47630, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Delmarva Heart Foundation
Salisbury, Maryland, 21804, United States
Beth Israel Deaconess
Boston, Massachusetts, 02215, United States
Washington University Medical School
Saint Louis, Michigan, 63110, United States
St. John Providence Hospital
Southfield, Michigan, 48075, United States
Lester E Cox Medical Center
Springfield, Missouri, 65807, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Associated Cardiovascular Consultants/Lourdes Cardiology Services
Voorhees Township, New Jersey, 08034, United States
North Shore LIJ
New York, New York, 10029, United States
New York Presbyterian Hospital
New York, New York, 10032, United States
Northeast Ohio Cardiovascular Specialists
Akron, Ohio, 44304, United States
The Lindner Research Center
Cincinnati, Ohio, 45219, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Doylestown Cardiology
Doylestown, Pennsylvania, 18901, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18722, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
St. Thomas Research Institute
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Amarillo Heart Group
Amarillo, Texas, 79106, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Centra Medical Group
Lynchburg, Virginia, 24510, United States
Heart Clinics Northwest
Spokane, Washington, 99204, United States
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, T2N 4Z6, Canada
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Fraser Clinical Trials
New Westminster, British Columbia, V3L 3W4, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
St. Paul's Hospital/Providence Health Care
Vancouver, British Columbia, V6E 1M7, Canada
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, V8Z 0B9, Canada
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Cardio 1
Winnipeg, Manitoba, R3L 1Z5, Canada
New Brunswick Heart Centre
Saint John, New Brunswick, E2L 2L4, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7, Canada
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario, L8L 2X2, Canada
University of Western Ontario
London, Ontario, N0L 1W0, Canada
Southlake
Newmarket, Ontario, L3Y 2P9, Canada
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3N5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
CHUM
Montreal, Quebec, H2W 1T8, Canada
McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5N4, Canada
Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)
Trois-Rivières, Quebec, G8Z 3R9, Canada
Prairie Vascular Research Network
Regina, Saskatchewan, S4P 0W5, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Quebec Heart Institute
Laval, G1V 4G5, 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, 37099, 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, 03010, Spain
Hospital Universitario Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Universitetssjukhuset Örebro
Örebro, 70185, Sweden
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
Great Western Hospital NHS Trust
Swindon, United Kingdom
Related Publications (1)
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.
PMID: 25589197DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Derek V Exner, MD, MPH
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Canada Research Chair in Cardiovascular Clinical Trials
Study Record Dates
First Submitted
April 29, 2008
First Posted
May 7, 2008
Study Start
April 18, 2011
Primary Completion
October 31, 2024
Study Completion
October 31, 2024
Last Updated
May 30, 2025
Record last verified: 2025-05