Back to resultsA Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy (CAPTURE)
Primary Purpose
Myocardial Infarction, Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Use of the ICD Critical Pathway
Sponsored by
About this trial
This is an interventional health services research trial for Myocardial Infarction focused on measuring Myocardial Infarction, Heart Failure, Sudden Cardiac Death, Critical Pathways
Eligibility Criteria
Inclusion Criteria:
- acute ST segment elevation myocardial infarction (STEMI)
- candidate for percutaneous revascularization
- permanent residents of British Columbia, Canada
Exclusion Criteria:
- patients with heart disease or a comorbid illness who have a documented life expectancy of less than 1 year
Sites / Locations
- St. Paul's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Critical Pathway
Standard Practice
Arm Description
Outcomes
Primary Outcome Measures
Rate of Referral for ICD Assessment
Secondary Outcome Measures
Rate of ICD Implantation
Full Information
NCT ID
NCT01248702
First Posted
November 22, 2010
Last Updated
March 6, 2012
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01248702
Brief Title
A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy
Acronym
CAPTURE
Official Title
A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Heart Failure
Keywords
Myocardial Infarction, Heart Failure, Sudden Cardiac Death, Critical Pathways
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Critical Pathway
Arm Type
Experimental
Arm Title
Standard Practice
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Use of the ICD Critical Pathway
Other Intervention Name(s)
ICD Critical Pathway
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Referral for ICD Assessment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of ICD Implantation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute ST segment elevation myocardial infarction (STEMI)
candidate for percutaneous revascularization
permanent residents of British Columbia, Canada
Exclusion Criteria:
patients with heart disease or a comorbid illness who have a documented life expectancy of less than 1 year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
S Cowan, MD, MSc
Phone
(604) 682 2344
Email
capture.study@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Cowan, MD, MSc
Organizational Affiliation
St. Paul's Hospital, Vancouver, British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
A Ignaszewski, MD
Organizational Affiliation
St. Paul's Hospital, Vancouver, British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
C Kerr, MD
Organizational Affiliation
St. Paul's Hospital, Vancouver, British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S Tung, MD
Organizational Affiliation
St. Paul's Hospital, Vancouver, British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Cowan, MD, MSc
Phone
(604) 682 2344
Email
capture.study@gmail.com
First Name & Middle Initial & Last Name & Degree
S Cowan, MD, MSc
First Name & Middle Initial & Last Name & Degree
A Ignaszewski, MD
First Name & Middle Initial & Last Name & Degree
C Kerr, MD
First Name & Middle Initial & Last Name & Degree
S Tung, MD
12. IPD Sharing Statement
Learn more about this trial
A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy
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