Myocardial InfarctionCAPTURENCT01248702
A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy
A study testing Use of the ICD Critical Pathway in people with Myocardial Infarction and Heart Failure, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to develop and implement a critical pathway to identify patients with ischemic cardiomyopathy who are candidates for an implantable cardioverter-defibrillator (ICD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Heart Failure
- What is being tested?
- Use of the ICD Critical Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to May 2012
- 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
- acute ST segment elevation myocardial infarction (STEMI)
- candidate for percutaneous revascularization
- permanent residents of British Columbia, Canada
Who cannot join
- patients with heart disease or a comorbid illness who have a documented life expectancy of less than 1 year
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
S Cowan, MD, MSc, (604) 682 2344, capture.study@gmail.com
S Cowan, MD, MSc
About this study
The purpose of this study is to develop and implement a critical pathway to identify patients with ischemic cardiomyopathy who are candidates for an implantable cardioverter-defibrillator (ICD). This study will also determine whether the use of the critical pathway for ICDs is associated with a change in the ICD referral and implantation rate.
Read the detailed description
Despite improvements in both medical management and revascularization strategies, sudden death is still a significant complication in patients with ischemic cardiomyopathy. There is strong evidence to support the role of ICDs for the primary prevention of sudden death in this population. However, in Canada and the United States, ICDs are underutilized.
Critical pathways are algorithms that improve health care delivery and clinical outcomes while reducing practice variability. The use of a critical pathway to assess a patient's eligibility for an ICD may increase the appropriate use of this evidence-based technology.
- Conditions
- Myocardial Infarction, Heart Failure
- Being tested
- Use of the ICD Critical Pathway
- Keywords
- Myocardial Infarction, Heart Failure, Sudden Cardiac Death, Critical Pathways
- Medical subject headings
- Myocardial Infarction, Heart Failure, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the ICD Critical PathwayOther
Also called ICD Critical Pathway
The critical pathway is a series of predetermined processes designed to assess a patient's eligibility for an ICD. The critical pathway will incorporate current evidence-based practice guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Critical Pathway | Experimental | Not described Receives: Other: Use of the ICD Critical Pathway |
| Standard Practice | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Referral for ICD Assessment
Measured: 1 year
Secondary outcomes (1)
Rate of ICD Implantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startApr 2012
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- S Cowan, MD, MSc, Study director, St. Paul's Hospital, Vancouver, British ColumbiaA Ignaszewski, MD, Study director, St. Paul's Hospital, Vancouver, British ColumbiaC Kerr, MD, Principal investigator, St. Paul's Hospital, Vancouver, British ColumbiaS Tung, MD, Study director, St. Paul's Hospital, Vancouver, British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248702
- Sponsor's protocol ID
- H10-01537
- Acronym
- CAPTURE
- Status last verified
- Mar 2012
- First submitted
- 22 Nov 2010
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01248702
- Acronym / sponsor ID
- CAPTURE / H10-01537
- Conditions
- Myocardial Infarction, Heart Failure
- Keywords
- Myocardial Infarction, Heart Failure, Sudden Cardiac Death, Critical Pathways
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 25 Nov 2010 (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.
The purpose of this study is to develop and implement a critical pathway to identify patients with ischemic cardiomyopathy who are candidates for an implantable cardioverter-defibrillator (ICD). This study will also determine whether the use of the critical pathway for ICDs is associated with a change in the ICD referral and implantation rate.
Detailed description
Despite improvements in both medical management and revascularization strategies, sudden death is still a significant complication in patients with ischemic cardiomyopathy. There is strong evidence to support the role of ICDs for the primary prevention of sudden death in this population. However, in Canada and the United States, ICDs are underutilized.
Critical pathways are algorithms that improve health care delivery and clinical outcomes while reducing practice variability. The use of a critical pathway to assess a patient's eligibility for an ICD may increase the appropriate use of this evidence-based technology.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critical Pathway | Experimental | Other: Use of the ICD Critical Pathway |
| Standard Practice | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute ST segment elevation myocardial infarction (STEMI)
- candidate for percutaneous revascularization
- permanent residents of British Columbia, Canada
Key exclusion criteria (1 listed)
- patients with heart disease or a comorbid illness who have a documented life expectancy of less than 1 year
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 |
|---|---|---|
| Use of the ICD Critical PathwayAlso: ICD Critical PathwayThe critical pathway is a series of predetermined processes designed to assess a patient's eligibility for an ICD. The critical pathway will incorporate current evidence-based practice guidelines. | Other | Critical Pathway |
Primary outcome
Rate of Referral for ICD Assessment
Time frame: 1 year
1 secondary outcome
Rate of ICD Implantation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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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.
S Cowan, MD, MSc study director
St. Paul's Hospital, Vancouver, British Columbia
A Ignaszewski, MD study director
St. Paul's Hospital, Vancouver, British Columbia
C Kerr, MD principal investigator
St. Paul's Hospital, Vancouver, British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the ICD Critical Pathway in people with Myocardial Infarction and Heart Failure, run by University of British Columbia at 1 site 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact S Cowan, MD, MSc ((604) 682 2344, capture.study@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Referral for ICD Assessment (time frame: 1 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 7 Mar 2012.