Myocardial Infarction Clinical Trial
— REFINE-ICDOfficial title:
Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy
NCT number | NCT00673842 |
Other study ID # | 21721 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | March 2011 |
Est. completion date | December 31, 2024 |
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 | Recruiting |
Enrollment | 700 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven - Campus Gasthuisberg | Leuven | |
Canada | Libin Cardiovascular Institute of Alberta | Calgary | Alberta |
Canada | Cambridge Cardiac Care Centre | Cambridge | Ontario |
Canada | Royal Alexandra Hospital | Edmonton | Alberta |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia |
Canada | Hamilton Health Sciences Centre | Hamilton | Ontario |
Canada | Hamilton Health Sciences II | Hamilton | Ontario |
Canada | Quebec Heart Institute | Laval | |
Canada | University of Western Ontario | London | Ontario |
Canada | CHUM | Montreal | Quebec |
Canada | McGill University Health Centre | Montreal | Quebec |
Canada | Montreal Heart Institute | Montreal | Quebec |
Canada | Fraser Clinical Trials | New Westminster | British Columbia |
Canada | Southlake | Newmarket | Ontario |
Canada | Ottawa Heart Institute | Ottawa | Ontario |
Canada | Prairie Vascular Research Network | Regina | Saskatchewan |
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Canada | Centre Hospitalier Universitaire de Sherbrooke (CHUS) | Sherbrooke | Quebec |
Canada | Memorial University of Newfoundland | St Johns | Newfoundland and Labrador |
Canada | New Brunswick Heart Centre | St. John | New Brunswick |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR) | Trois-Rivieres | Quebec |
Canada | St. Paul's Hospital/Providence Health Care | Vancouver | British Columbia |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Canada | Victoria Cardiac Arrhythmia Trials | Victoria | British Columbia |
Canada | Cardio 1 | Winnipeg | Manitoba |
Canada | St. Boniface Hospital | Winnipeg | Manitoba |
Finland | HUCH Helsinki University Central Hospital | Helsinki | |
Finland | University of Oulu | Oulu | |
France | CHRU Brest - Hôpital de la Cavale Blanche | Brest | |
France | Hôpital Guillaume et René Laënnec - CHU de Nantes | Nantes | |
France | Hôpital Guillaume et René Laënnec - CHU de Nantes | Nantes | |
France | Clinique Pasteur | Toulouse | |
Germany | Universitätsmedizin Göttingen Georg-August-Universität | Göttingen | |
Hungary | Zala Megyei Kórház | Zalaegerszeg | |
Italy | Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | |
Italy | Policlinico Sant' Orsola - Malpighi | Bologna | |
Italy | Fondazione IRCCS Policlinico San Matteo | Pavia | |
Norway | Oslo Universitetssykehus Rikshospitalet | Oslo | |
Saudi Arabia | King Saud University | Riyadh | |
Slovakia | Slovak Medical University in Bratislava | Bratislava | |
South Africa | Unitas Hospital | Centurion | |
Spain | Hospital General Universitario de Alicante (HGUA) | Alicante | |
Spain | Hospital Universitario Clinic de Barcelona | Barcelona | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Sweden | Universitetssjukhuset Örebro | Örebro | |
United Kingdom | Liverpool Heart and Chest Hospital | Liverpool | |
United Kingdom | Great Western Hospital NHS Trust | Swindon | |
United States | Northeast Ohio Cardiovascular Specialists | Akron | Ohio |
United States | Amarillo Heart Group | Amarillo | Texas |
United States | Beth Israel Deaconess | Boston | Massachusetts |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | University of Virginia | Charlottesville | Virginia |
United States | Bethesda North Hospital | Cincinnati | Ohio |
United States | The Lindner Research Center | Cincinnati | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | South Carolina Heart Center | Columbia | South Carolina |
United States | The Ohio State University | Columbus | Ohio |
United States | Doylestown Cardiology | Doylestown | Pennsylvania |
United States | Hamot Medical Center | Erie | Pennsylvania |
United States | The Heart Group/Deaconess | Evansville | Indiana |
United States | Pee Dee Cardiology | Florence | South Carolina |
United States | Cardiovascular Consultants Heart Center | Fresno | California |
United States | Greenville Hospital System | Greenville | South Carolina |
United States | Hartford Hospital | Hartford | Connecticut |
United States | Heart Center Research LLC | Huntsville | Alabama |
United States | Watson Clinic | Lakeland | Florida |
United States | Colorado Heart and Vascular | Lakewood | Colorado |
United States | Centra Medical Group | Lynchburg | Virginia |
United States | Aurora St. Luke's Medical Center/Aurora Cardiovascular Services | Milwaukee | Wisconsin |
United States | Wheaton Franciscan Healthcare | Milwaukee | Wisconsin |
United States | St. Thomas Research Institute | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Yale University | New Haven | Connecticut |
United States | New York Presbyterian Hospital | New York | New York |
United States | North Shore LIJ | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center UPMC Presbyterian | Pittsburgh | Pennsylvania |
United States | The Valley Hospital | Ridgewood | New Jersey |
United States | Washington University Medical School | Saint Louis | Michigan |
United States | Delmarva Heart Foundation | Salisbury | Maryland |
United States | St. John Providence Hospital | Southfield | Michigan |
United States | Spartanburg Regional Healthcare System | Spartanburg | South Carolina |
United States | Heart Clinics Northwest | Spokane | Washington |
United States | Lester E Cox Medical Center | Springfield | Missouri |
United States | James A Haley Veterans' Center | Tampa | Florida |
United States | Scott & White Healthcare | Temple | Texas |
United States | Associated Cardiovascular Consultants/Lourdes Cardiology Services | Voorhees | New Jersey |
United States | Iowa Heart Center | West Des Moines | Iowa |
United States | Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Accelerating Clinical Trials Consortium, Alberta Innovation and Science, Canadian Institutes of Health Research (CIHR), Cardiac Arrhythmia Network of Canada, GE Healthcare, Medtronic |
United States, Belgium, Canada, Finland, France, Germany, Hungary, Italy, Norway, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | Minimum of 18 months of follow-up (average follow-up of 5 years). | ||
Secondary | Cardiac death | Average follow-up 5 years. | ||
Secondary | Arrhythmic death | Average follow-up 5 years. | ||
Secondary | Arrhythmic syncope | Average follow-up 5 years. | ||
Secondary | Appropriate ICD therapies | Average follow-up 5 years. | ||
Secondary | Quality of life | Average follow-up 5 years. | ||
Secondary | Inappropriate ICD therapies | Five years (average) |
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