Status:
COMPLETED
Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Alberta Innovation and Science
Conditions:
Myocardial Infarction
Sudden Death
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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, a...
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 18 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00673842
Start Date
April 18 2011
End Date
October 31 2024
Last Update
May 30 2025
Active Locations (79)
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1
Heart Center Research LLC
Huntsville, Alabama, United States, 35801
2
Colorado Heart and Vascular
Lakewood, Colorado, United States, 80228
3
James A Haley Veterans' Center
Tampa, Florida, United States, 33612
4
The Heart Group/Deaconess
Evansville, Indiana, United States, 47630