Coronary Heart DiseaseSMART-ICDNCT00524862
Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death
A study testing Optimized medical therapy and Implantable Cardioverter Defibrillator in people with Coronary Heart Disease and Congestive Heart Failure, run by Unity Health Toronto at 10 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Congestive Heart Failure, Ventricular Dysfunction
- What is being tested?
- Optimized medical therapy and Implantable Cardioverter Defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 10 sitesCanada
- Study dates
- Oct 2007to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Hamilton Health Sciences - Hamilton General
Hamilton, Ontario, L8L 2X2
Kingston General Hospital
Kingston, Ontario, K7L 2V7
London Health Sciences - University Campus
London, Ontario, N6A 5A5
Trillium Health Centre - Mississauga
Mississauga, Ontario, L5B 1B8
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Rouge Valley Health System - Centenary
Scarborough Village, Ontario, M1E 5E9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD
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.
- Conditions
- Coronary Heart Disease, Congestive Heart Failure, Ventricular Dysfunction, Low Cardiac Output, Sudden Cardiac Death
- Being tested
- Optimized medical therapy, Implantable Cardioverter Defibrillator
- Keywords
- Implantable Cardioverter Defibrillator, Ejection Fraction, QRS duration
- Medical subject headings
- Coronary Disease, Heart Failure, Ventricular Dysfunction, Cardiac Output, Low, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized medical therapyDrug
Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
Implantable Cardioverter DefibrillatorDevice
Also called ICD
an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: Optimized medical therapy |
| 2 | Other | Not described Receives: Device: Implantable Cardioverter Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: minimum 1 year follow-up (maximum 6 year)
Secondary outcomes (1)
1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications
Measured: minimum 1 year; maximum 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences, Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- Paul Dorian, MD, Study chair, Unity Health TorontoAndreas Laupacis, MD, Study director, Li Ka Shing Knowledge Institute at St. Michael's HospitalDouglas Lee, MD, Study director, Institute for Clinical Evaluatuve SciencesKevin Thorpe, MSc, Study director, Li Ka Shing Knowledge Institute at St. Michael's HospitalMarta Gadacz, MSc, Study director, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524862
- Sponsor's protocol ID
- 06368
- Acronym
- SMART-ICD
- Status last verified
- Jul 2015
- First submitted
- 29 Aug 2007
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD
- ClinicalTrials.gov ID
- NCT00524862
- Acronym / sponsor ID
- SMART-ICD / 06368
- Conditions
- Coronary Heart Disease, Congestive Heart Failure, Ventricular Dysfunction, Low Cardiac Output, Sudden Cardiac Death
- Keywords
- Implantable Cardioverter Defibrillator, Ejection Fraction, QRS duration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences, Ontario Ministry of Health and Long Term Care
- Study start
- Oct 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Optimized medical therapy |
| 2 | Other | Device: Implantable Cardioverter Defibrillator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized medical therapyBeta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated | Drug | 1 |
| Implantable Cardioverter DefibrillatorAlso: ICDan implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly | Device | 2 |
Primary outcome
All-cause mortality
Time frame: minimum 1 year follow-up (maximum 6 year)
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Dorian, MD study chair
Unity Health Toronto
Andreas Laupacis, MD study director
Li Ka Shing Knowledge Institute at St. Michael's Hospital
Douglas Lee, MD study director
Institute for Clinical Evaluatuve Sciences
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized medical therapy and Implantable Cardioverter Defibrillator in people with Coronary Heart Disease and Congestive Heart Failure, run by Unity Health Toronto at 10 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: minimum 1 year follow-up (maximum 6 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.