Southfield, Michigan 48075

  • Sudden Death

Purpose:

This study will assess whether an implantable defibrillator will increase the likelihood of survival in patients who have had a heart attack in the prior 5 years, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.


Study summary:

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.


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 and < / = 60 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 2 to 60 months after a confirmed MI, > / = 3 months after coronary angioplasty or coronary bypass surgery and < / = 6 months of the screening visit - Proven, necessary or appropriate medications (e.g. beta-blocker, ACE inhibitor / ARB, statin, and anti-platelet) - In normal sinus rhythm (ECG documented) within the two 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 2 to 60 months after the index MI and the specified time after coronary revascularization 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


NCT ID:

NCT00673842


Primary Contact:

Principal Investigator
Derek V Exner, MD, MPH
University of Calgary

Derek V Exner, MD, MPH
Phone: 403-220-3219
Email: exner@ucalgary.ca


Backup Contact:

Email: letanmes@ucalgary.ca
Caroline (Liong Eng) Tan-Mesiatowsky, MD
Phone: 403-210-7396


Location Contact:

Southfield, Michigan 48075
United States

Cordell Hastings
Email: Cordell.Hastings@providence-stjohnhealth.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 03, 2022

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