NCT00524862 (SMART-ICD) is a NA clinical trial of Optimized medical therapy in Coronary Heart Disease, sponsored by Unity Health Toronto.

Who is sponsoring NCT00524862?

NCT00524862 is sponsored by Unity Health Toronto.

What drugs are being tested in NCT00524862?

Interventions in NCT00524862: Optimized medical therapy, Implantable Cardioverter Defibrillator.

What condition does NCT00524862 study?

NCT00524862 studies Coronary Heart Disease, Congestive Heart Failure, Ventricular Dysfunction, Low Cardiac Output, Sudden Cardiac Death.

Is NCT00524862 still recruiting?

NCT00524862 is currently terminated. Last updated 30 July 2015.

Last reviewed 2015-07-30 · How we verify

NCT00524862: SMART-ICD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD

Terminated NA Last updated 30 July 2015

What this trial tests

NA trial testing Optimized medical therapy in Coronary Heart Disease in 5,000 participants. Terminated before completion.

Timeline

1 October 2007

Primary endpoint
1 April 2011

1 April 2011

Quick facts

Lead sponsor	Unity Health Toronto
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	5,000
Start date	1 October 2007
Primary completion	1 April 2011
Estimated completion	1 April 2011
Sites	10 locations across Canada

Drugs / interventions tested

Optimized medical therapy — full drug profile →
Implantable Cardioverter Defibrillator

Conditions studied

Coronary Heart Disease — all drugs for Coronary Heart Disease →
Congestive Heart Failure — all drugs for Congestive Heart Failure →
Ventricular Dysfunction — all drugs for Ventricular Dysfunction →
Low Cardiac Output — all drugs for Low Cardiac Output →

Sponsor

Unity Health Toronto — full company profile →

Who can join

18 and older, any sex, with Coronary Heart Disease or Congestive Heart Failure. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

All-cause mortality
Time frame: minimum 1 year follow-up (maximum 6 year)

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Coronary Heart Disease

Currently open trials in the same condition.

NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
NCT07230847 — A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug- · NA · recruiting
NCT07110415 — Efficacy and Safety Trials of Yangxinshi Tablets in the Treatment of Patients With Coronary Heart Disease Complicated by · Phase 4 · recruiting
NCT07451873 — Glycocalyx and Oxidative Stress in Endothelial Function (Part 2) · recruiting
NCT07118930 — Study of Sivelestat Sodium in OPCABG · Phase 2 · recruiting

Other Unity Health Toronto trials

Trials by the same sponsor.

NCT07507409 — Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients · Phase 4 · not yet recruiting
NCT07455487 — First Appendectomy Using Revolve Surgical Robotic Arm · NA · not yet recruiting
NCT07301632 — Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial · Phase 2 · recruiting
NCT07314905 — Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) · Phase 3 · not yet recruiting
NCT06571916 — Brief Skills for Safer Living (Brief-SfSL) · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00524862 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Unity Health Toronto
Last refreshed: 30 July 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00524862.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing