Myocardial InfarctionPhase 3REFINE-ICDNCT00673842
Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction
A Phase 3 study of Myocardial Infarction and Sudden Death, run by University of Calgary at 79 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, Sudden Death
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 79 sitesin 15 countries
- Study dates
- 18 Apr 2011to 31 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
79 sites in 15 countries.
79 sites in 15 countries
United States29 sites
Northeast Ohio Cardiovascular Specialists
Akron, Ohio, 44304
Amarillo Heart Group
Amarillo, Texas, 79106
Beth Israel Deaconess
Boston, Massachusetts, 02215
University of Virginia
Charlottesville, Virginia, 22908
The Lindner Research Center
Cincinnati, Ohio, 45219
Bethesda North Hospital
Cincinnati, Ohio, 45242
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
Doylestown Cardiology
Doylestown, Pennsylvania, 18901
The Heart Group/Deaconess
Evansville, Indiana, 47630
Greenville Hospital System
Greenville, South Carolina, 29605
Heart Center Research LLC
Huntsville, Alabama, 35801
Colorado Heart and Vascular
Lakewood, Colorado, 80228
Centra Medical Group
Lynchburg, Virginia, 24510
St. Thomas Research Institute
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
North Shore LIJ
New York, New York, 10029
New York Presbyterian Hospital
New York, New York, 10032
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
The Valley Hospital
Ridgewood, New Jersey, 07450
Washington University Medical School
Saint Louis, Michigan, 63110
Delmarva Heart Foundation
Salisbury, Maryland, 21804
St. John Providence Hospital
Southfield, Michigan, 48075
Heart Clinics Northwest
Spokane, Washington, 99204
Lester E Cox Medical Center
Springfield, Missouri, 65807
James A Haley Veterans' Center
Tampa, Florida, 33612
Associated Cardiovascular Consultants/Lourdes Cardiology Services
Voorhees Township, New Jersey, 08034
Iowa Heart Center
West Des Moines, Iowa, 50266
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18722
Canada27 sites
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, T2N 4Z6
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
Hamilton Health Sciences Centre
Hamilton, Ontario, L8L 2X2
Quebec Heart Institute
Laval, G1V 4G5
University of Western Ontario
London, Ontario, N0L 1W0
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
CHUM
Montreal, Quebec, H2W 1T8
McGill University Health Centre
Montreal, Quebec, H3G 1A4
Fraser Clinical Trials
New Westminster, British Columbia, V3L 3W4
Southlake
Newmarket, Ontario, L3Y 2P9
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Prairie Vascular Research Network
Regina, Saskatchewan, S4P 0W5
New Brunswick Heart Centre
Saint John, New Brunswick, E2L 2L4
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5N4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3N5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)
Trois-Rivières, Quebec, G8Z 3R9
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
St. Paul's Hospital/Providence Health Care
Vancouver, British Columbia, V6E 1M7
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, V8Z 0B9
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Cardio 1
Winnipeg, Manitoba, R3L 1Z5
Spain5 sites
Hospital General Universitario de Alicante (HGUA)
Alicante, 03010
Hospital Universitario Clinic de Barcelona
Barcelona, 08036
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario La Paz
Madrid
France3 sites
CHRU Brest - Hôpital de la Cavale Blanche
Brest
Hôpital Guillaume et René Laënnec - CHU de Nantes
Nantes
Clinique Pasteur
Toulouse
Italy3 sites
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo
Policlinico Sant' Orsola - Malpighi
Bologna
Fondazione IRCCS Policlinico San Matteo
Pavia
Finland2 sites
HUCH Helsinki University Central Hospital
Helsinki
University of Oulu
Oulu
United Kingdom2 sites
Liverpool Heart and Chest Hospital
Liverpool
Great Western Hospital NHS Trust
Swindon
Germany1 site
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, 37099
About this study
Official title: Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy
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.
Read the 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.
- Conditions
- Myocardial Infarction, Sudden Death
- Being tested
- Implantable Cardioverter Defibrillator + Usual Care, Usual care
- Keywords
- Noninvasive assessment, Holter
- Medical subject headings
- Myocardial Infarction, Death, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardioverter Defibrillator + Usual CareDevice
Also called Implantable Cardioverter Defibrillator, ICD
Any Medtronic approved single chamber or dual chamber implantable cardioverter defibrillator (ICD)
Usual careOther
Also called Standard medical therapy alone
Usual post-MI care
| Study group | Role | What they receive |
|---|---|---|
| ICD + Usual Care | Experimental | Implantable Cardioverter Defibrillator + Usual Care Receives: Device: Implantable Cardioverter Defibrillator + Usual Care |
| Usual Care | Active comparator | Usual post-MI care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: Minimum of 18 months of follow-up (average follow-up of 5 years).
Secondary outcomes (6)
Cardiac death
Measured: Average follow-up 5 years.
Arrhythmic death
Measured: Average follow-up 5 years.
Arrhythmic syncope
Measured: Average follow-up 5 years.
Appropriate ICD therapies
Measured: Average follow-up 5 years.
Quality of life
Measured: Average follow-up 5 years.
Inappropriate ICD therapies
Measured: Five years (average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study start18 Apr 2011
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Innovation and Science, Medtronic, GE Healthcare, Cardiac Arrhythmia Network of Canada, Accelerating Clinical Trials Consortium
- Responsible party
- Principal investigator, Dr. Derek Exner, University of Calgary
- Investigators
- Derek V Exner, MD, MPH, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673842
- Sponsor's protocol ID
- 21721
- Acronym
- REFINE-ICD
- Status last verified
- May 2025
- First submitted
- 29 Apr 2008
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: uncertain
Publications
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.
PubMed 25589197
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy
- ClinicalTrials.gov ID
- NCT00673842
- Acronym / sponsor ID
- REFINE-ICD / 21721
- Conditions
- Myocardial Infarction, Sudden Death
- Keywords
- Noninvasive assessment, Holter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Innovation and Science, Medtronic, GE Healthcare, Cardiac Arrhythmia Network of Canada, Accelerating Clinical Trials Consortium
- Study start
- 18 Apr 2011 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICD + Usual Care | Experimental | Device: Implantable Cardioverter Defibrillator + Usual CareImplantable Cardioverter Defibrillator + Usual Care |
| Usual Care | Active comparator | Other: Usual careUsual post-MI care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Cardioverter Defibrillator + Usual CareAlso: Implantable Cardioverter Defibrillator, ICDAny Medtronic approved single chamber or dual chamber implantable cardioverter defibrillator (ICD) | Device | ICD + Usual Care |
| Usual careAlso: Standard medical therapy aloneUsual post-MI care | Other | Usual Care |
Primary outcome
Mortality
Time frame: Minimum of 18 months of follow-up (average follow-up of 5 years).
6 secondary outcomes
Cardiac death
Time frame: Average follow-up 5 years.
Arrhythmic death
Time frame: Average follow-up 5 years.
Arrhythmic syncope
Time frame: Average follow-up 5 years.
Appropriate ICD therapies
Time frame: Average follow-up 5 years.
Quality of life
Time frame: Average follow-up 5 years.
Inappropriate ICD therapies
Time frame: Five years (average)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 25589197Perkiomaki 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.
- Individual participant dataSharing planned: Undecided. uncertain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek V Exner, MD, MPH principal investigator
University of Calgary
79 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Myocardial Infarction and Sudden Death, run by University of Calgary at 79 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Canada, Spain, France, Italy and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Minimum of 18 months of follow-up (average follow-up of 5 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00673842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.