NCT00673842CompletedPhase 3
Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction
Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy
Source: ClinicalTrials.gov · Last updated 30 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- First submitted
- 29 Apr 2008
- Start date
- 18 Apr 2011
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- University of Calgary
- Diseases
- Coronary artery disease
- NCT number
- NCT00673842
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 700
- From 18 Apr 2011 to the primary completion date, 31 Oct 2024
- 78 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antiarrhythmic drugs
- Prior implantation of a pacemaker, ICD, or Cardiac Resynchronization device
- Active ischemia that is amenable to revascularization if not previously revascularized
Other illness
- Clinical indication for permanent pacemaker or a cardiac resynchronization device
- Clinical indication for an ICD or cardiac resynchronization ICD
- Any condition, in the investigator's judgment, that would limit life expectancy to \< 12 months
- Chronic renal failure (hemodialysis or peritoneal dialysis)
Other
- Participation in another trial that may interfere with the REFINE ICD results.
- Pregnancy
- Inability to comply with the follow-up schedule
Criteria the registry did not label
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (78)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uz Leuven Campus Gasthuisberg Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Libin Cardiovascular Institute of Alberta Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Cambridge Cardiac Care Centre Coordinator of this site? Confirm its status | Cambridge | Canada | Unknown status |
| Royal Alexandra Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Queen Elizabeth II Health Sciences Center Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Hamilton Health Sciences Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Quebec Heart Institute Coordinator of this site? Confirm its status | Laval | Canada | Unknown status |
| University of Western Ontario Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| CHUM Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Southlake Coordinator of this site? Confirm its status | Newmarket | Canada | Unknown status |
| Fraser Clinical Trials Coordinator of this site? Confirm its status | New Westminster | Canada | Unknown status |
| Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Prairie Vascular Research Network Coordinator of this site? Confirm its status | Regina | Canada | Unknown status |
| New Brunswick Heart Centre Coordinator of this site? Confirm its status | Saint John | Canada | Unknown status |
| Royal University Hospital Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
| Centre hospitalier universitaire de Sherbrooke (CHUS) Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR) Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| St. Paul's Hospital - Providence Health Care Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Victoria Cardiac Arrhythmia Trials Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
| Cardio 1 Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| St. Boniface Hospital Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Universitätsmedizin Göttingen - Georg-August-Universität Coordinator of this site? Confirm its status | Göttingen | Germany | Unknown status |
| Hospital General Universitario de Alicante (HGUA) Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitario Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| HUCH Helsinki University Central Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| University Of Oulu Coordinator of this site? Confirm its status | Oulu | Finland | Unknown status |
| CHRU Brest - Hôpital de la Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Hôpital Guillaume et René Laënnec - CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Liverpool Heart and Chest Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Great Western Hospital NHS Trust Coordinator of this site? Confirm its status | Swindon | United Kingdom | Unknown status |
| Zala Megyei Kórház Coordinator of this site? Confirm its status | Zalaegerszeg | Hungary | Unknown status |
| Azienda Ospedaliera Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Policlinico Sant'Orsola-Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Oslo Universitetssykehus Rikshospitalet Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| King Saud University Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Universitetssjukhuset Örebro Coordinator of this site? Confirm its status | Örebro | Sweden | Unknown status |
| Slovak Medical University in Bratislava Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| Northeast Ohio Cardiovascular Specialists Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| Amarillo Heart Group Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Beth Israel Deaconess Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Bethesda North Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| The Lindner Research Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Doylestown Cardiology Coordinator of this site? Confirm its status | Doylestown | United States | Unknown status |
| The Heart Group/Deaconess Coordinator of this site? Confirm its status | Evansville | United States | Unknown status |
| Greenville Hospital System Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Heart Center Research, LLC Coordinator of this site? Confirm its status | Huntsville | United States | Unknown status |
| Colorado Heart and Vascular Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Centra Medical Group Coordinator of this site? Confirm its status | Lynchburg | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| St. Thomas Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| New York - Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| North Shore LIJ Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pittsburgh Medical Center UPMC Presbyterian Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| The Valley Hospital Coordinator of this site? Confirm its status | Ridgewood | United States | Unknown status |
| Washington University Medical School Coordinator of this site? Confirm its status | Saint Louis | United States | Unknown status |
| Delmarva Heart Foundation Coordinator of this site? Confirm its status | Salisbury | United States | Unknown status |
| St. John Providence Hospital Coordinator of this site? Confirm its status | Southfield | United States | Unknown status |
| Heart Clinics Northwest Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Lester E Cox Medical Center Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| James A Haley Veterans' Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Associated Cardiovascular Consultants/Lourdes Cardiology Services Coordinator of this site? Confirm its status | Voorhees Township | United States | Unknown status |
| Iowa Heart Center Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| Geisinger Wyoming Valley Medical Center Coordinator of this site? Confirm its status | Wilkes-Barre | United States | Unknown status |
| Unitas Hospital Coordinator of this site? Confirm its status | Centurion | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.