Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction

Phase 3

Completed

• Conditions: Myocardial Infarction; Sudden Death

• Registration Number: NCT00673842
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-07
• Study Start: 2011-04-18
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-26
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mortality	Minimum of 18 months of follow-up (average follow-up of 5 years).

Secondary Outcome Measures

Name	Time	Method
Appropriate ICD therapies	Average follow-up 5 years.
Arrhythmic syncope	Average follow-up 5 years.
Arrhythmic death	Average follow-up 5 years.
Inappropriate ICD therapies	Five years (average)
Quality of life	Average follow-up 5 years.
Cardiac death	Average follow-up 5 years.

Trial Locations

Locations (78)

Heart Center Research LLC; 🇺🇸 Huntsville, Alabama, United States

Colorado Heart and Vascular; 🇺🇸 Lakewood, Colorado, United States

James A Haley Veterans' Center; 🇺🇸 Tampa, Florida, United States

The Heart Group/Deaconess; 🇺🇸 Evansville, Indiana, United States

Iowa Heart Center; 🇺🇸 West Des Moines, Iowa, United States

Delmarva Heart Foundation; 🇺🇸 Salisbury, Maryland, United States

Beth Israel Deaconess; 🇺🇸 Boston, Massachusetts, United States

Washington University Medical School; 🇺🇸 Saint Louis, Michigan, United States

St. John Providence Hospital; 🇺🇸 Southfield, Michigan, United States

Lester E Cox Medical Center; 🇺🇸 Springfield, Missouri, United States

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