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A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy (CAPTURE)

This study is not yet open for participant recruitment.
Verified March 2012 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01248702
First received: November 22, 2010
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Myocardial Infarction
Heart Failure
 Other: Use of the ICD Critical Pathway

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Rate of Referral for ICD Assessment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of ICD Implantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: April 2012
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Critical Pathway Other: Use of the 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.
Other Name: ICD Critical Pathway
No Intervention: Standard Practice

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248702

Contacts
Contact: S Cowan, MD, MSc (604) 682 2344 capture.study@gmail.com

Locations
Canada, British Columbia
St. Paul's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: S Cowan, MD, MSc     (604) 682 2344     capture.study@gmail.com    
Sub-Investigator: S Cowan, MD, MSc            
Sub-Investigator: A Ignaszewski, MD            
Principal Investigator: C Kerr, MD            
Sub-Investigator: S Tung, MD            
Sponsors and Collaborators
University of British Columbia
Investigators
Study Director: S Cowan, MD, MSc St. Paul's Hospital, Vancouver, British Columbia
Study Director: A Ignaszewski, MD St. Paul's Hospital, Vancouver, British Columbia
Principal Investigator: C Kerr, MD St. Paul's Hospital, Vancouver, British Columbia
Study Director: S Tung, MD St. Paul's Hospital, Vancouver, British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01248702     History of Changes
Other Study ID Numbers: H10-01537
Study First Received: November 22, 2010
Last Updated: March 6, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Myocardial Infarction
Heart Failure
Sudden Cardiac Death
Critical Pathways

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
 Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013