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

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

Genetics Home Reference related topics:

Brugada syndrome short QT syndrome

MedlinePlus related topics:

Cardiac Arrest Heart Diseases Heart Failure Pacemakers and Implantable Defibrillators

ChemIDplus related topics:

Warfarin Warfarin potassium Warfarin sodium Acetylsalicylic acid Spironolactone

U.S. FDA Resources

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

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

Contacts


Contact: Paul Dorian, MD	416.864.5104	dorianp@smh.toronto.on.ca

Contact: Marta Gadacz, MSc	416.864.5379	gadaczm@smh.toronto.on.ca

Locations


Canada, Ontario
	St. Michael's Hospital	Recruiting
	Toronto, Ontario, Canada, M5B 1W8
	Contact: Theresa Aves 416.864.5621 avest@smh.toronto.on.ca
	Principal Investigator: Arnold Pinter, MD
	Rouge Valley Health System - Centenary	Recruiting
	Scarborough, Ontario, Canada, M1E 5E9
	Contact: Bev Bozek 416.281.7591 bev@screserach.ca
	Principal Investigator: Amir Janmohammed, MD
	Sub-Investigator: Ted Davies, MD
	Sub-Investigator: Joseph Ricci, MD
	London Health Sciences - University Campus	Recruiting
	London, Ontario, Canada, N6A 5A5
	Contact: Cathy Bentley 519.685.8500 ext 32835 cbentl@uwo.ca
	Principal Investigator: Lorne Gula, MD
	Trillium Health Centre - Mississauga	Recruiting
	Mississauga, Ontario, Canada, L5B 1B8
	Contact: Cynthia Young cyoung@thc.on.ca
	Principal Investigator: Cathy LeFeuvre, MD
	Hamilton Health Sciences - Hamilton General	Recruiting
	Hamilton, Ontario, Canada, L8L 2X2
	Principal Investigator: Jeff Healey, MD
	University of Ottawa Heart Institute	Recruiting
	Ottawa, Ontario, Canada, K1Y 4W7
	Contact: Karen MacDonald kmacdonald@ottawaheart.ca
	Principal Investigator: David Birnie, MD
	University Health Network - Toronto General Hospital	Recruiting
	Toronto, Ontario, Canada, M5G 2C4
	Contact: Ann Hill 416.340.4800 ext 3744 ann.hill@uhn.on.ca
	Principal Investigator: Douglas Cameron
	Sunnybrook Health Sciences Centre	Recruiting
	Toronto, Ontario, Canada, M4N 3M5
	Contact: Victoria Yuen 416.480.6100 ext 7537 victoria.yuen@sunnybrook.ca
	Principal Investigator: Eugene Crystal, MD
	Kingston General Hospital	Recruiting
	Kingston, Ontario, Canada, K7L 2V7
	Contact: Sharon Fair 613.549.6666 ext 3156 fairs@kgh.kari.net
	Principal Investigator: Chris Simpson, MD
	Sub-Investigator: Damien Redfearn, MD
	Southlake Regional Health Centre	Recruiting
	Newmarket, Ontario, Canada, L3Y 2P9
	Contact: Annette Nath 905.895.4521 anath@southlakeregional.org
	Principal Investigator: Zaev Wulffhart, MD

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

Responsible Party:	St. Michael's Hospital ( Prinicipal Investigator )
Study ID Numbers:	06368
First Received:	August 29, 2007
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00524862
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

Study placed in the following topic categories:

Ventricular Dysfunction

Heart Failure

Death

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Heart Arrest

Warfarin

Ischemia

Spironolactone

Cardiac Output, Low

Coronary Disease

Signs and Symptoms

Aspirin

Death, Sudden

Death, Sudden, Cardiac

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	St. Michael's Hospital, Toronto 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