Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death
Information source: St. Michael's Hospital, Toronto
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Heart Disease; Congestive Heart Failure; Ventricular Dysfunction; Low Cardiac Output; Sudden Cardiac Death
Intervention: Optimized medical therapy (Drug); Implantable Cardioverter Defibrillator (Device)
Phase: N/A
Status: Recruiting
Sponsored by: St. Michael's Hospital, Toronto Official(s) and/or principal investigator(s):
Paul Dorian, MD, Study Chair, Affiliation: St. Michael's Hospital, Toronto
Andreas Laupacis, MD, Study Director, Affiliation: Li Ka Shing Knowledge Institute at St. Michael's Hospital
Douglas Lee, MD, Study Director, Affiliation: Institute for Clinical Evaluatuve Sciences
Kevin Thorpe, MSc, Study Director, Affiliation: Li Ka Shing Knowledge Institute at St. Michael's Hospital
Marta Gadacz, MSc, Study Director, Affiliation: St. Michael's Hospital, Toronto
Overall contact:
Paul Dorian, MD, Phone: 416.864.5104, Email: dorianp@smh.toronto.on.ca
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.
Clinical Details
Official title: Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment
Primary outcome: All-cause mortality
Secondary outcome: 1. Presumed arrhythmic (sudden death) mortality.
2. Major morbidity which includes mortality, hospitalization and major device complications
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Paul Dorian, MD, Phone: 416.864.5104, Email: dorianp@smh.toronto.on.ca
St. Michael's Hospital, Toronto, Ontario M5B 1W8, Canada; Recruiting
Theresa Aves, Phone: 416.864.5621, Email: avest@smh.toronto.on.ca
Arnold Pinter, MD, Principal Investigator
Rouge Valley Health System - Centenary, Scarborough, Ontario M1E 5E9, Canada; Recruiting
Bev Bozek, Phone: 416.281.7591, Email: bev@screserach.ca
Amir Janmohammed, MD, Principal Investigator
Ted Davies, MD, Sub-Investigator
Joseph Ricci, MD, Sub-Investigator
London Health Sciences - University Campus, London, Ontario N6A 5A5, Canada; Recruiting
Cathy Bentley, Phone: 519.685.8500, Ext: 32835, Email: cbentl@uwo.ca
Lorne Gula, MD, Principal Investigator
Trillium Health Centre - Mississauga, Mississauga, Ontario L5B 1B8, Canada; Recruiting
Cynthia Young, Email: cyoung@thc.on.ca
Cathy LeFeuvre, MD, Principal Investigator
Hamilton Health Sciences - Hamilton General, Hamilton, Ontario L8L 2X2, Canada; Recruiting
Jeff Healey, MD, Principal Investigator
Southlake Regional Health Centre, Newmarket, Ontario L3Y 2P9, Canada; Recruiting
Annette Nath, Phone: 905.895.4521, Email: anath@southlakeregional.org
Zaev Wulffhart, MD, Principal Investigator
University Health Network - Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada; Recruiting
Ann Hill, Phone: 416.340.4800, Ext: 3744, Email: ann.hill@uhn.on.ca
Douglas Cameron, Principal Investigator
Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada; Recruiting
Victoria Yuen, Phone: 416.480.6100, Ext: 7537, Email: victoria.yuen@sunnybrook.ca
Eugene Crystal, MD, Principal Investigator
Kingston General Hospital, Kingston, Ontario K7L 2V7, Canada; Recruiting
Sharon Fair, Phone: 613.549.6666, Ext: 3156, Email: fairs@kgh.kari.net
Chris Simpson, MD, Principal Investigator
Damien Redfearn, MD, Sub-Investigator
University of Ottawa Heart Institute, Ottawa, Ontario K1Y 4W7, Canada; Recruiting
Karen MacDonald, Email: kmacdonald@ottawaheart.ca
David Birnie, MD, Principal Investigator
Additional Information
Starting date: October 2007
Ending date: April 2011
Last updated: September 2, 2008
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