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The trial is taking place at:
C

Cambridge Cardiac Care Centre | Cambridge, Canada

Veeva-enabled site

Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction (REFINE-ICD)

U

University of Calgary

Status and phase

Enrolling
Phase 3

Conditions

Myocardial Infarction
Sudden Death

Treatments

Other: Usual care
Device: Implantable Cardioverter Defibrillator + Usual Care

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

700 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

700 participants in 2 patient groups

Implantable Cardioverter Defibrillator + Usual Care
Experimental group
Description:
Medtronic ICD
Treatment:
Device: Implantable Cardioverter Defibrillator + Usual Care
Usual Care
Active Comparator group
Description:
Usual post-MI care
Treatment:
Other: Usual care

Trial contacts and locations

95

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Central trial contact

Derek V Exner, MD, MPH; Caroline Tan-Mesiatowsky, MD

Data sourced from clinicaltrials.gov

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