Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death

NCT ID: NCT00524862

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-04-30

Brief Summary

Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF < 40%. Current Canadian guidelines recommend ICDs for primary prophylaxis in CAD patients with LVEF < 30% (Class I recommendation). There are very sparse data to recommend ICD implantation in patients with EF between 30 and 40 %. This study will randomize patients with CHD and an EF between 30 and 40% to ICD therapy vs. No ICD therapy. The primary outcome is mortality and the study is powered as a non-inferiority trial to test the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute yearly increase) than patients receiving an ICD.

Conditions

Coronary Heart Disease; Congestive Heart Failure; Ventricular Dysfunction; Low Cardiac Output; Sudden Cardiac Death

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Group Type: OTHER

Optimized medical therapy

Intervention Type: DRUG

Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated

2

Group Type: OTHER

Implantable Cardioverter Defibrillator

Intervention Type: DEVICE

an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly

Interventions

Optimized medical therapy

Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated

Intervention Type: DRUG

Implantable Cardioverter Defibrillator

an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly

Intervention Type: DEVICE

Other Intervention Names

ICD

Eligibility Criteria

Inclusion Criteria

• documented chronic coronary heart disease (prior MI and/or angiographically documented CAD), > 40 days post the most recent MI;
• LVEF < 40% (by MUGA) and NYHA functional class II or III at time of assessment OR LVEF ≤ 35 % (by MUGA) and NYHA functional class I, II or III at time of assessment
• Judged to have a reasonable expectation of survival with a good functional status for more than 1 year, as well as receiving optimum, guideline recommended therapy for coronary artery disease and heart failure (or demonstrated intolerance or contraindications to such therapy).
• Age ≥ 18 years; no upper age limitation.

Exclusion Criteria

• Prior cardiac arrest, sustained VT or VF, or unexplained syncope.
• Attempted VT / VF induction at electrophysiological study.
• Need for a cardiac resynchronization therapy (CRT) device.
• Enrollment in another interventional trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute for Clinical Evaluative Sciences

OTHER

Sponsor Role: collaborator

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Dorian, MD

Role: STUDY_CHAIR

Unity Health Toronto

Andreas Laupacis, MD

Role: STUDY_DIRECTOR

Li Ka Shing Knowledge Institute at St. Michael's Hospital

Douglas Lee, MD

Role: STUDY_DIRECTOR

Institute for Clinical Evaluatuve Sciences

Kevin Thorpe, MSc

Role: STUDY_DIRECTOR

Li Ka Shing Knowledge Institute at St. Michael's Hospital

Marta Gadacz, MSc

Role: STUDY_DIRECTOR

Unity Health Toronto

Locations

Hamilton Health Sciences - Hamilton General

Hamilton, Ontario, Canada

Kingston General Hospital

Kingston, Ontario, Canada

London Health Sciences - University Campus

London, Ontario, Canada

Trillium Health Centre - Mississauga

Mississauga, Ontario, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Rouge Valley Health System - Centenary

Scarborough Village, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

06368

Identifier Type: -

Identifier Source: org_study_id