- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00673842
Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction (REFINE-ICD)
Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Derek V Exner, MD, MPH
- Phone Number: 403-220-3219
- Email: exner@ucalgary.ca
Study Contact Backup
- Name: Caroline Tan-Mesiatowsky, MD
- Phone Number: 403-210-7396
- Email: letanmes@ucalgary.ca
Study Locations
-
-
-
Leuven, Belgium
- Active, not recruiting
- UZ Leuven - Campus Gasthuisberg
-
-
-
-
-
Laval, Canada, G1V 4G5
- Recruiting
- Quebec Heart Institute
-
Contact:
- Marie-Eve Boucher, RN
- Email: marie-eve.boucher.2@criucpq.ulaval.ca
-
Principal Investigator:
- Francois Philippon, MD
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4Z6
- Recruiting
- Libin Cardiovascular Institute of Alberta
-
Contact:
- Wei Qi, MD, PhD
- Email: wqi@ucalgary.ca
-
Principal Investigator:
- Katherine Kavanagh, MD
-
Edmonton, Alberta, Canada, T6G 2B7
- Recruiting
- University of Alberta Hospital
-
Principal Investigator:
- Tomasz Hruczkowski, MD
-
Edmonton, Alberta, Canada, T5H 3V9
- Recruiting
- Royal Alexandra Hospital
-
Principal Investigator:
- Evan Lockwood, MD
-
Contact:
- Rebecca Cairns
- Email: Rebecca.Cairns@ahs.ca
-
-
British Columbia
-
New Westminster, British Columbia, Canada, V3L 3W4
- Recruiting
- Fraser Clinical Trials
-
Principal Investigator:
- John LeMaitre, MD
-
Contact:
- Gus Silverio
- Email: gsilverio@fraserclinicaltrials.com
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Recruiting
- Vancouver General Hospital
-
Contact:
- Ngaire Meadows, RN
- Email: ngaire.meadows2@vch.ca
-
Principal Investigator:
- Matthew Bennett, MD
-
Vancouver, British Columbia, Canada, V6E 1M7
- Recruiting
- St. Paul's Hospital/Providence Health Care
-
Principal Investigator:
- Marc Deyell, MD
-
Contact:
- Elisa Ramser, PhD
- Email: eramser@providencehealth.bc.ca
-
Victoria, British Columbia, Canada, V8Z 0B9
- Recruiting
- Victoria Cardiac Arrhythmia Trials
-
Principal Investigator:
- Laurence Sterns, MD
-
Contact:
- Matthew Coxon, BSc
- Email: mcoxon@catrials.org
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R2H 2A6
- Recruiting
- St. Boniface Hospital
-
Contact:
- Rebecca Fromm, RN
- Email: rfromm2@sbgh.mb.ca
-
Principal Investigator:
- Colette Seifer, MD
-
Winnipeg, Manitoba, Canada, R3L 1Z5
- Recruiting
- Cardio 1
-
Contact:
- Rose Ramm, RN
- Email: rramm@cardio1.ca
-
Principal Investigator:
- Peiman M. Marzban, MD
-
-
New Brunswick
-
St. John, New Brunswick, Canada, E2L 2L4
- Recruiting
- New Brunswick Heart Centre
-
Principal Investigator:
- Satish Toal, MD
-
Contact:
- Jennifer McLaughlin, RN
- Email: jenniferlynn.mclaughlin@horizonNB.ca
-
-
Newfoundland and Labrador
-
St Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Withdrawn
- Memorial University of Newfoundland
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 3A7
- Recruiting
- Queen Elizabeth II Health Sciences Center
-
Contact:
- Victoria Newman, RN
- Email: victoria.newman@nshealth.ca
-
Principal Investigator:
- John Sapp, MD
-
-
Ontario
-
Cambridge, Ontario, Canada, N1R 6V6
- Recruiting
- Cambridge Cardiac Care Centre
-
Contact:
- Lauren Turpin
- Email: lauren.turpincccc@gmail.com
-
Principal Investigator:
- A. Shekhar Pandey, MD
-
Hamilton, Ontario, Canada, L8L 2X2
- Recruiting
- Hamilton Health Sciences Centre
-
Principal Investigator:
- Jeffrey Healey, MD
-
Contact:
- Andrea Afinec
- Email: afinec@hhsc.ca
-
Hamilton, Ontario, Canada, L8L 2X2
- Withdrawn
- Hamilton Health Sciences II
-
London, Ontario, Canada, N0L 1W0
- Recruiting
- University of Western Ontario
-
Contact:
- Samuel Triemstra, BSc
- Email: samuel.triemstra@lhsc.on.ca
-
Principal Investigator:
- Anthony Tang, MD
-
Newmarket, Ontario, Canada, L3Y 2P9
- Recruiting
- Southlake
-
Principal Investigator:
- Yaariv Khaykin, MD
-
Contact:
- Annette Nath, RN
- Email: anath@southlake.ca
-
Ottawa, Ontario, Canada, K1Y 4W7
- Recruiting
- Ottawa Heart Institute
-
Principal Investigator:
- David Birnie, MD
-
Contact:
- Madhuri Thommandru
- Email: mthommandru@ottawaheart.ca
-
Toronto, Ontario, Canada, M5B 1W8
- Recruiting
- St. Michael's Hospital
-
Principal Investigator:
- Paul Angaran, MD
-
Contact:
- Marta Gadacz
- Email: marta.gadacz@unityhealth.to
-
Toronto, Ontario, Canada, M5G 2C4
- Recruiting
- Toronto General Hospital
-
Principal Investigator:
- Andrew Ha, MD
-
Toronto, Ontario, Canada, M4N 3N5
- Recruiting
- Sunnybrook Health Sciences Centre
-
Contact:
- Ambreen Syeda
- Email: ambreen.syeda@sunnybrook.ca
-
Principal Investigator:
- Eugene Crystal, MD
-
-
Quebec
-
Montreal, Quebec, Canada, H1T 1C8
- Recruiting
- Montreal Heart Institute
-
Contact:
- Francois Lemarbre, RN
- Email: francois.lemarbre@icm-mhi.org
-
Principal Investigator:
- Bernard Thibault, MD
-
Montreal, Quebec, Canada, H3G 1A4
- Recruiting
- McGill University Health Centre
-
Principal Investigator:
- Vidal Essebag, MD, PhD
-
Contact:
- Fiorella Rafti, PhD
- Email: fiorella.rafti@mail.mcgill.ca
-
Montreal, Quebec, Canada, H2W 1T8
- Recruiting
- CHUM
-
Contact:
- Martine Bergeron
- Email: martine.bergeron.chum@ssss.gouv.qc.ca
-
Principal Investigator:
- Benoit Coutu, MD
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Recruiting
- Centre hospitalier universitaire de Sherbrooke (CHUS)
-
Principal Investigator:
- Mariano Badra-Verdu, MD
-
Contact:
- Nadia Vachon, RN
- Email: nadia.vachon.ciussse-chus@ssss.gouv.qc.ca
-
Trois-Rivieres, Quebec, Canada, G8Z 3R9
- Recruiting
- Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)
-
Principal Investigator:
- Ariel Diaz, MD
-
Contact:
- Mariana Dias, RN
- Email: Mariana.Costa-Dias@ssss.gouv.qc.ca
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4P 0W5
- Recruiting
- Prairie Vascular Research Network
-
Principal Investigator:
- Omar Sultan, MD
-
Principal Investigator:
- Payam Dehghani, MD
-
Contact:
- Neha Mehta, PhD
- Email: nmehta.pvri@gmail.com
-
Saskatoon, Saskatchewan, Canada, S7N 0W8
- Recruiting
- Royal University Hospital
-
Principal Investigator:
- Kelly Coverett, MD
-
Contact:
- Crystal Shendaruk, RN
- Email: crystal.shendaruk@saskhealthauthority.ca
-
-
-
-
-
Helsinki, Finland
- Active, not recruiting
- HUCH Helsinki University Central Hospital
-
Oulu, Finland
- Active, not recruiting
- University of Oulu
-
-
-
-
-
Brest, France
- Completed
- CHRU Brest - Hôpital de la Cavale Blanche
-
Nantes, France, 44093
- Completed
- Hôpital Guillaume et René Laënnec - CHU de Nantes
-
Nantes, France
- Completed
- Hôpital Guillaume et René Laënnec - CHU de Nantes
-
Toulouse, France
- Completed
- Clinique Pasteur
-
-
-
-
-
Göttingen, Germany, 37099
- Completed
- Universitätsmedizin Göttingen Georg-August-Universität
-
-
-
-
-
Zalaegerszeg, Hungary
- Active, not recruiting
- Zala Megyei Kórház
-
-
-
-
-
Bergamo, Italy
- Completed
- Azienda Ospedaliera Papa Giovanni XXIII
-
Bologna, Italy
- Completed
- Policlinico Sant' Orsola - Malpighi
-
Pavia, Italy
- Active, not recruiting
- Fondazione IRCCS Policlinico San Matteo
-
-
-
-
-
Oslo, Norway
- Active, not recruiting
- Oslo Universitetssykehus Rikshospitalet
-
-
-
-
-
Riyadh, Saudi Arabia
- Active, not recruiting
- King Saud University
-
-
-
-
-
Bratislava, Slovakia
- Active, not recruiting
- Slovak Medical University in Bratislava
-
-
-
-
-
Centurion, South Africa
- Active, not recruiting
- Unitas Hospital
-
-
-
-
-
Alicante, Spain, 03010
- Completed
- Hospital General Universitario de Alicante (HGUA)
-
Barcelona, Spain, 08036
- Completed
- Hospital Universitario Clinic de Barcelona
-
Madrid, Spain
- Completed
- Hospital Universitario La Paz
-
Madrid, Spain, 28046
- Completed
- Hospital Universitario La Paz
-
Madrid, Spain
- Completed
- Hospital Universitario 12 de Octubre
-
-
-
-
-
Örebro, Sweden, 70185
- Completed
- Universitetssjukhuset Orebro
-
-
-
-
-
Liverpool, United Kingdom
- Completed
- Liverpool Heart and Chest Hospital
-
Swindon, United Kingdom
- Completed
- Great Western Hospital NHS Trust
-
-
-
-
Alabama
-
Huntsville, Alabama, United States, 35801
- Completed
- Heart Center Research LLC
-
-
California
-
Fresno, California, United States, 93720
- Withdrawn
- Cardiovascular Consultants Heart Center
-
-
Colorado
-
Lakewood, Colorado, United States, 80228
- Completed
- Colorado Heart and Vascular
-
-
Connecticut
-
Hartford, Connecticut, United States, 06106
- Withdrawn
- Hartford Hospital
-
New Haven, Connecticut, United States, 06519
- Withdrawn
- Yale University
-
-
Florida
-
Lakeland, Florida, United States, 33805
- Withdrawn
- Watson Clinic
-
Tampa, Florida, United States, 33612
- Completed
- James A Haley Veterans' Center
-
-
Indiana
-
Evansville, Indiana, United States, 47630
- Completed
- The Heart Group/Deaconess
-
-
Iowa
-
West Des Moines, Iowa, United States, 50266
- Completed
- Iowa Heart Center
-
-
Maryland
-
Salisbury, Maryland, United States, 21804
- Completed
- Delmarva Heart Foundation
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Completed
- Beth Israel Deaconess
-
-
Michigan
-
Saint Louis, Michigan, United States, 63110
- Completed
- Washington University Medical School
-
Southfield, Michigan, United States, 48075
- Completed
- St. John Providence Hospital
-
-
Missouri
-
Springfield, Missouri, United States, 65807
- Completed
- Lester E Cox Medical Center
-
-
New Jersey
-
Ridgewood, New Jersey, United States, 07450
- Completed
- The Valley Hospital
-
Voorhees, New Jersey, United States, 08034
- Terminated
- Associated Cardiovascular Consultants/Lourdes Cardiology Services
-
-
New York
-
New York, New York, United States, 10029
- Completed
- North Shore LIJ
-
New York, New York, United States, 10032
- Completed
- New York Presbyterian Hospital
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28203
- Withdrawn
- Carolinas Medical Center
-
-
Ohio
-
Akron, Ohio, United States, 44304
- Completed
- Northeast Ohio Cardiovascular Specialists
-
Cincinnati, Ohio, United States, 45219
- Completed
- The Lindner Research Center
-
Cincinnati, Ohio, United States, 45242
- Completed
- Bethesda North Hospital
-
Cleveland, Ohio, United States, 44195
- Completed
- Cleveland Clinic
-
Columbus, Ohio, United States, 43210
- Completed
- The Ohio State University
-
-
Pennsylvania
-
Doylestown, Pennsylvania, United States, 18901
- Completed
- Doylestown Cardiology
-
Erie, Pennsylvania, United States, 16550
- Withdrawn
- Hamot Medical Center
-
Philadelphia, Pennsylvania, United States, 19104
- Withdrawn
- University of Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Completed
- University of Pittsburgh Medical Center UPMC Presbyterian
-
Wilkes-Barre, Pennsylvania, United States, 18722
- Completed
- Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Columbia, South Carolina, United States, 29204
- Withdrawn
- South Carolina Heart Center
-
Florence, South Carolina, United States, 29506
- Withdrawn
- Pee Dee Cardiology
-
Greenville, South Carolina, United States, 29605
- Completed
- Greenville Hospital System
-
Spartanburg, South Carolina, United States, 29303
- Withdrawn
- Spartanburg Regional Healthcare System
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Completed
- Vanderbilt University Medical Center
-
Nashville, Tennessee, United States, 37203
- Terminated
- St. Thomas Research Institute
-
-
Texas
-
Amarillo, Texas, United States, 79106
- Completed
- Amarillo Heart Group
-
Temple, Texas, United States, 76508
- Withdrawn
- Scott & White Healthcare
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Completed
- University of Virginia
-
Lynchburg, Virginia, United States, 24510
- Completed
- Centra Medical Group
-
-
Washington
-
Spokane, Washington, United States, 99204
- Active, not recruiting
- Heart Clinics Northwest
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53210
- Withdrawn
- Wheaton Franciscan Healthcare
-
Milwaukee, Wisconsin, United States, 53215
- Withdrawn
- Aurora St. Luke's Medical Center/Aurora Cardiovascular Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Implantable Cardioverter Defibrillator + Usual Care
Medtronic ICD
|
Any Medtronic approved single chamber or dual chamber implantable cardioverter defibrillator (ICD)
Other Names:
|
Active Comparator: Usual Care
Usual post-MI care
|
Usual post-MI care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: Minimum of 18 months of follow-up (average follow-up of 5 years).
|
Minimum of 18 months of follow-up (average follow-up of 5 years).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiac death
Time Frame: Average follow-up 5 years.
|
Average follow-up 5 years.
|
Arrhythmic death
Time Frame: Average follow-up 5 years.
|
Average follow-up 5 years.
|
Arrhythmic syncope
Time Frame: Average follow-up 5 years.
|
Average follow-up 5 years.
|
Appropriate ICD therapies
Time Frame: Average follow-up 5 years.
|
Average follow-up 5 years.
|
Quality of life
Time Frame: Average follow-up 5 years.
|
Average follow-up 5 years.
|
Inappropriate ICD therapies
Time Frame: Five years (average)
|
Five years (average)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Derek V Exner, MD, MPH, University of Calgary
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21721
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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