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

University of Calgary

Status and phase: Active, not recruiting; 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

NCT00673842

21721

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)

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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