Clinical trial NCT00524862: Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death
Official title: Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Heart Disease
Congestive Heart Failure
Ventricular Dysfunction
Low Cardiac Output
Sudden Cardiac Death
Keywords: Implantable Cardioverter Defibrillator
Ejection Fraction
QRS duration
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Institute for Clinical Evaluative Sciences
name: Ontario Ministry of Health and Long Term Care
First posted: 2007-09-05
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: All-cause mortality
timeFrame: minimum 1 year follow-up (maximum 6 year)
Secondary outcomes:
measure: 1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications
timeFrame: minimum 1 year; maximum 6 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Hamilton General
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences - University Campus
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Centre - Mississauga
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Scarborough
country: Canada
facility: Rouge Valley Health System - Centenary
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Paul Dorian, MD
role: STUDY_CHAIR
affiliation: Li Ka Shing Knowledge Institute at St. Michael's Hospital
name: Andreas Laupacis, MD
role: STUDY_DIRECTOR
affiliation: Institute for Clinical Evaluatuve Sciences
name: Douglas Lee, MD
role: STUDY_DIRECTOR
affiliation: Li Ka Shing Knowledge Institute at St. Michael's Hospital
name: Kevin Thorpe, MSc
role: STUDY_DIRECTOR
affiliation: Unity Health Toronto
name: Marta Gadacz, MSc
role: STUDY_DIRECTOR
References: