Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death - Full Text View

Sponsor:	St. Michael's Hospital, Toronto
Collaborators:	Institute for Clinical Evaluative Sciences Ontario Ministry of Health and Long Term Care
Information provided by:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT00524862

Purpose

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.

Condition	Intervention
Coronary Heart Disease Congestive Heart Failure Ventricular Dysfunction Low Cardiac Output Sudden Cardiac Death	Drug: Optimized medical therapy Device: Implantable Cardioverter Defibrillator

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Cardiac Arrest Coronary Artery Disease Heart Diseases Heart Failure Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:

All-cause mortality [ Time Frame: minimum 1 year follow-up (maximum 6 year) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications [ Time Frame: minimum 1 year; maximum 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	5000
Study Start Date:	October 2007
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	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
2	Device: Implantable Cardioverter Defibrillator an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524862

Locations

Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Rouge Valley Health System - Centenary
Scarborough, Ontario, Canada, M1E 5E9
London Health Sciences - University Campus
London, Ontario, Canada, N6A 5A5
Trillium Health Centre - Mississauga
Mississauga, Ontario, Canada, L5B 1B8
Hamilton Health Sciences - Hamilton General
Hamilton, Ontario, Canada, L8L 2X2
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Institute for Clinical Evaluative Sciences

Ontario Ministry of Health and Long Term Care

Investigators

Study Chair:	Paul Dorian, MD	St. Michael's Hospital, Toronto
Study Director:	Andreas Laupacis, MD	Li Ka Shing Knowledge Institute at St. Michael's Hospital
Study Director:	Douglas Lee, MD	Institute for Clinical Evaluatuve Sciences
Study Director:	Kevin Thorpe, MSc	Li Ka Shing Knowledge Institute at St. Michael's Hospital
Study Director:	Marta Gadacz, MSc	St. Michael's Hospital, Toronto

More Information

No publications provided

Responsible Party:	St. Michael's Hospital ( Prinicipal Investigator )
Study ID Numbers:	06368
Study First Received:	August 29, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00524862 History of Changes
Health Authority:	Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by St. Michael's Hospital, Toronto:

Implantable Cardioverter Defibrillator
Ejection Fraction
QRS duration

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Ventricular Dysfunction
Death
Heart Failure
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Heart Arrest
Arteriosclerosis

Cardiac Output, Low
Coronary Disease
Signs and Symptoms
Pathologic Processes
Death, Sudden
Cardiovascular Diseases
Death, Sudden, Cardiac
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 09, 2009