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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00524862
Other study ID # 06368
Secondary ID
Status Terminated
Phase N/A
First received August 29, 2007
Last updated July 30, 2015
Start date October 2007
Est. completion date April 2011

Study information

Verified date July 2015
Source St. Michael's Hospital, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Ministry of Health & Long Term Care, Ontario
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 5000
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Drug:
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
Device:
Implantable Cardioverter Defibrillator
an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly

Locations

Country Name City State
Canada 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 Ontario
Canada St. Michael's Hospital Toronto Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario
Canada University Health Network - Toronto General Hospital Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto Institute for Clinical Evaluative Sciences, Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality minimum 1 year follow-up (maximum 6 year) No
Secondary 1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications minimum 1 year; maximum 6 years No
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