Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction (REFINE-ICD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00673842
Recruitment Status : Recruiting
First Posted : May 7, 2008
Last Update Posted : July 11, 2016
Canadian Institutes of Health Research (CIHR)
Alberta Innovation and Science
GE Healthcare
Information provided by (Responsible Party):
Dr. Derek Exner, 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 in the prior 5 years, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Sudden Death Device: Implantable Cardioverter Defibrillator + Usual Care Other: Usual care Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy
Study Start Date : March 2011
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Implantable Cardioverter Defibrillator + Usual Care
Medtronic ICD
Device: Implantable Cardioverter Defibrillator + Usual Care
Any Medtronic approved (in each geography) single chamber or dual chamber implantable cardioverter defibrillator (ICD)
Other Names:
  • Implantable Cardioverter Defibrillator
  • ICD

Active Comparator: Usual Care
Usual post-MI care
Other: Usual care
Usual post-MI care
Other Name: Standard medical therapy alone

Primary Outcome Measures :
  1. Mortality [ Time Frame: Minimum of 18 months of follow-up (average follow-up of 5 years). ]

Secondary Outcome Measures :
  1. Cardiac death [ Time Frame: Average follow-up 5 years. ]
  2. Arrhythmic death [ Time Frame: Average follow-up 5 years. ]
  3. Arrhythmic syncope [ Time Frame: Average follow-up 5 years. ]
  4. Appropriate ICD therapies [ Time Frame: Average follow-up 5 years. ]
  5. Quality of life [ Time Frame: Average follow-up 5 years. ]
  6. Inappropriate ICD therapies [ Time Frame: Five years (average) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 and < / = 60 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 2 to 60 months after a confirmed MI, > / = 3 months after coronary angioplasty or coronary bypass surgery and < / = 6 months of the screening visit
  • Proven, necessary or appropriate medications (e.g. beta-blocker, ACE inhibitor / ARB, statin, and anti-platelet)
  • In normal sinus rhythm (ECG documented) within the two 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 2 to 60 months after the index MI and the specified time after coronary revascularization

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00673842

Contact: Derek V Exner, MD, MPH 403-220-3219
Contact: Caroline (Liong Eng) Tan-Mesiatowsky, MD 403-210-7396

  Hide Study Locations
United States, Alabama
Heart Center Research LLC Recruiting
Huntsville, Alabama, United States, 35801
Contact: Jessica Marsh, RN    256-519-8143   
Principal Investigator: Jay Dinerman, MD         
Heart Center Research LLC Completed
Huntsville, Alabama, United States, 35801
United States, California
Cardiovascular Consultants Heart Center Withdrawn
Fresno, California, United States, 93720
United States, Colorado
Colorado Heart and Vascular Completed
Lakewood, Colorado, United States, 80228
United States, Connecticut
Hartford Hospital Withdrawn
Hartford, Connecticut, United States, 06106
Yale University Withdrawn
New Haven, Connecticut, United States, 06519
United States, Florida
Watson Clinic Withdrawn
Lakeland, Florida, United States, 33805
James A Haley Veterans' Center Completed
Tampa, Florida, United States, 33612
United States, Indiana
The Heart Group/Deaconess Active, not recruiting
Evansville, Indiana, United States, 47630
United States, Iowa
Iowa Heart Center Active, not recruiting
West Des Moines, Iowa, United States, 50266
United States, Maryland
Delmarva Heart Foundation Completed
Salisbury, Maryland, United States, 21804
United States, Massachusetts
Beth Israel Deaconess Completed
Boston, Massachusetts, United States, 02215
United States, Michigan
Washington University Medical School Active, not recruiting
Saint Louis, Michigan, United States, 63110
St. John Providence Hospital Recruiting
Southfield, Michigan, United States, 48075
Contact: Cordell Hastings   
Principal Investigator: Christian Michado, MD         
United States, Missouri
Lester E Cox Medical Center Active, not recruiting
Springfield, Missouri, United States, 65807
United States, New Jersey
The Valley Hospital Completed
Ridgewood, New Jersey, United States, 07450
Associated Cardiovascular Consultants/Lourdes Cardiology Services Terminated
Voorhees, New Jersey, United States, 08034
United States, New York
North Shore LIJ Completed
New York, New York, United States, 10029
New York Presbyterian Hospital Completed
New York, New York, United States, 10032
United States, North Carolina
Carolinas Medical Center Withdrawn
Charlotte, North Carolina, United States, 28203
United States, Ohio
Northeast Ohio Cardiovascular Specialists Completed
Akron, Ohio, United States, 44304
The Lindner Research Center Completed
Cincinnati, Ohio, United States, 45219
Bethesda North Hospital Completed
Cincinnati, Ohio, United States, 45242
Cleveland Clinic Completed
Cleveland, Ohio, United States, 44195
The Ohio State University Completed
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Doylestown Cardiology Completed
Doylestown, Pennsylvania, United States, 18901
Hamot Medical Center Withdrawn
Erie, Pennsylvania, United States, 16550
University of Pennsylvania Withdrawn
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center UPMC Presbyterian Completed
Pittsburgh, Pennsylvania, United States, 15213
Geisinger Wyoming Valley Medical Center Completed
Wilkes-Barre, Pennsylvania, United States, 18722
United States, South Carolina
South Carolina Heart Center Withdrawn
Columbia, South Carolina, United States, 29204
Pee Dee Cardiology Withdrawn
Florence, South Carolina, United States, 29506
Greenville Hospital System Active, not recruiting
Greenville, South Carolina, United States, 29605
Spartanburg Regional Healthcare System Withdrawn
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
St. Thomas Research Institute Terminated
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Amarillo Heart Group Active, not recruiting
Amarillo, Texas, United States, 79106
Scott & White Healthcare Withdrawn
Temple, Texas, United States, 76508
United States, Virginia
University of Virginia Completed
Charlottesville, Virginia, United States, 22908
Centra Medical Group Completed
Lynchburg, Virginia, United States, 24510
United States, Washington
Heart Clinics Northwest Active, not recruiting
Spokane, Washington, United States, 99204
United States, Wisconsin
Wheaton Franciscan Healthcare Withdrawn
Milwaukee, Wisconsin, United States, 53210
Aurora St. Luke's Medical Center/Aurora Cardiovascular Services Withdrawn
Milwaukee, Wisconsin, United States, 53215
UZ Leuven - Campus Gasthuisberg Active, not recruiting
Leuven, Belgium
Canada, Alberta
Libin Cardiovascular Institute of Alberta Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Micheline Deschenes, PhD   
Principal Investigator: Katherine M Kavanagh, MD         
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Sylvia Martin, RN   
Principal Investigator: Evan Lockwood, MD         
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Maria Raines, RN   
Principal Investigator: Tomasz Hruczkowski, MD         
Canada, British Columbia
Fraser Clinical Trials Recruiting
New Westminster, British Columbia, Canada, V3L 3W4
Contact: Shirley Lim-Uy, RN   
Principal Investigator: John LeMaitre, MD         
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Ngaire Meadows, RN   
Principal Investigator: Matthew Bennett, MD         
St. Paul's Hospital/Providence Health Care Recruiting
Vancouver, British Columbia, Canada, V6E 1M7
Contact: Marion Thomas   
Principal Investigator: Marc Deyell, MD         
Victoria Cardiac Arrhythmia Trials Recruiting
Victoria, British Columbia, Canada, V8R 4R2
Contact: Deborah Parfett, RN   
Principal Investigator: Laurence Sterns, MD         
Canada, Manitoba
St. Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Rebecca Medeiros, RN   
Principal Investigator: Colette Seifer, MD         
Canada, New Brunswick
New Brunswick Heart Centre Recruiting
St. John, New Brunswick, Canada, E2L 2L4
Contact: Gail O' Blenis, RN   
Principal Investigator: Satish Toal, MD         
Canada, Newfoundland and Labrador
Memorial University of Newfoundland Recruiting
St Johns, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Diane Spurrell, RN   
Principal Investigator: Sean Connors, MD, PhD         
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Lisa Hebert, RN   
Principal Investigator: John Sapp, MD         
Canada, Ontario
Hamilton Health Sciences Centre Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Ruth Chinchilla, RN   
Principal Investigator: Jeffrey Healey, MD         
Hamilton Health Sciences II Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Sonya Brons, RN   
Principal Investigator: Shamir Mehta, MD         
University of Western Ontario Recruiting
London, Ontario, Canada, N0L 1W0
Contact: Patricia Burrows, RN   
Contact: , RN         
Principal Investigator: Raymond Yee, MD         
Southlake Recruiting
Newmarket, Ontario, Canada, L3Y 2P9
Contact: Annette Nath, RN   
Principal Investigator: Yaariv Khaykin, MD         
Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Tammy Knight, RN   
Principal Investigator: Girish Nair, MD         
Sub-Investigator: David Birnie, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3N5
Contact: Fahema Ahmadzai, RN   
Principal Investigator: Eugene Crystal, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Marta Gadacz   
Principal Investigator: Paul Angaran, MD         
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Ann Hill, RN   
Principal Investigator: Andrew Ha, MD         
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Francois Lemarbre, RN   
Principal Investigator: Bernard Thibault, MD         
CHUM Recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Martine Bergeron   
Principal Investigator: Benoit Coutu, MD         
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Fiorella Rafti   
Principal Investigator: Vidal Essebag, MD, PhD         
Centre Hospitalier Universitaire de Sherbrooke (CHUS) Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Veronique Dagenais, RN   
Principal Investigator: Mariano Badra-Verdu, MD         
Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR) Recruiting
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Contact: Isabelle Roy, RN   
Principal Investigator: Ariel Diaz, MD         
Canada, Saskatchewan
Prairie Vascular Research Network Recruiting
Regina, Saskatchewan, Canada, S4P 0W5
Contact: Sheila Kelly   
Principal Investigator: Omar Sultan, MD         
Principal Investigator: Payam Dehghani, MD         
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Lynn Zinger   
Principal Investigator: Kelly Coverett, MD         
Quebec Heart Institute Recruiting
Laval, Canada, G1V 4G5
Contact: Julie Robinson, RN   
Principal Investigator: Francois Philippon, MD         
HUCH Helsinki University Central Hospital Active, not recruiting
Helsinki, Finland
University of Oulu Active, not recruiting
Oulu, Finland
CHRU Brest - Hôpital de la Cavale Blanche Completed
Brest, France
Hôpital Guillaume et René Laënnec - CHU de Nantes Completed
Nantes, France, 44093
Hôpital Guillaume et René Laënnec - CHU de Nantes Completed
Nantes, France
Clinique Pasteur Completed
Toulouse, France
Universitätsmedizin Göttingen Georg-August-Universität Completed
Göttingen, Germany, 37099
Zala Megyei Kórház Completed
Zalaegerszeg, Hungary
Azienda Ospedaliera Papa Giovanni XXIII Completed
Bergamo, Italy
Policlinico Sant' Orsola - Malpighi Completed
Bologna, Italy
Fondazione IRCCS Policlinico San Matteo Completed
Pavia, Italy
Oslo Universitetssykehus Rikshospitalet Active, not recruiting
Oslo, Norway
Saudi Arabia
King Saud University Active, not recruiting
Riyadh, Saudi Arabia
Slovak Medical University in Bratislava Completed
Bratislava, Slovakia
South Africa
Unitas Hospital Active, not recruiting
Centurion, South Africa
Hospital General Universitario de Alicante (HGUA) Completed
Alicante, Spain, 03010
Hospital Universitario Clinic de Barcelona Completed
Barcelona, Spain, 08036
Hospital Universitario La Paz Completed
Madrid, Spain, 28046
Hospital Universitario 12 de Octubre Active, not recruiting
Madrid, Spain
Hospital Universitario La Paz Completed
Madrid, Spain
Universitetssjukhuset Örebro Completed
Örebro, Sweden, 70185
United Kingdom
Liverpool Heart and Chest Hospital Completed
Liverpool, United Kingdom
Great Western Hospital NHS Trust Completed
Swindon, United Kingdom
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Alberta Innovation and Science
GE Healthcare
Principal Investigator: Derek V Exner, MD, MPH University of Calgary

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Derek Exner, Professor and Canada Research Chair in Cardiovascular Clinical Trials, University of Calgary Identifier: NCT00673842     History of Changes
Other Study ID Numbers: 21721
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: uncertain

Keywords provided by Dr. Derek Exner, University of Calgary:
Noninvasive assessment

Additional relevant MeSH terms:
Myocardial Infarction
Death, Sudden
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases