Myocardial Infarction, Sudden Death
Conditions
Keywords
Noninvasive assessment, Holter
Brief 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.
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.
Interventions
DEVICEImplantable Cardioverter Defibrillator + Usual Care
Any Medtronic approved single chamber or dual chamber implantable cardioverter defibrillator (ICD)
OTHERUsual care
Usual post-MI care
Sponsors
Canadian Institutes of Health Research (CIHR)
Alberta Innovation and Science
Medtronic
GE Healthcare
Cardiac Arrhythmia Network of Canada
Accelerating Clinical Trials Consortium
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | Minimum of 18 months of follow-up (average follow-up of 5 years). |
Secondary
| Measure | Time frame |
|---|---|
| Arrhythmic death | Average follow-up 5 years. |
| Arrhythmic syncope | Average follow-up 5 years. |
| Cardiac death | Average follow-up 5 years. |
| Quality of life | Average follow-up 5 years. |
| Inappropriate ICD therapies | Five years (average) |
| Appropriate ICD therapies | Average follow-up 5 years. |
Countries
Belgium, Canada, Finland, France, Germany, Hungary, Italy, Norway, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, United Kingdom, United States
Outcome results
None listed