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

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ClinicalTrials.gov Identifier: NCT01248702
Recruitment Status : Unknown
Verified March 2012 by University of British Columbia.
Recruitment status was:  Not yet recruiting
First Posted : November 25, 2010
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Heart Failure Other: Use of the ICD Critical Pathway Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy
Study Start Date : April 2012
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Rate of Referral for ICD Assessment [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Rate of ICD Implantation [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01248702     History of Changes
Other Study ID Numbers: H10-01537
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

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