Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-25 @ 5:08 AM
Study NCT ID:
NCT01248702
Status:
UNKNOWN
Last Update Posted:
2012-03-07
First Post:
2010-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-06', 'studyFirstSubmitDate': '2010-11-22', 'studyFirstSubmitQcDate': '2010-11-23', 'lastUpdatePostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Referral for ICD Assessment', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Rate of ICD Implantation', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myocardial Infarction', 'Heart Failure', 'Sudden Cardiac Death', 'Critical Pathways'], 'conditions': ['Myocardial Infarction', 'Heart Failure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nCritical 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute ST segment elevation myocardial infarction (STEMI)\n* candidate for percutaneous revascularization\n* permanent residents of British Columbia, Canada\n\nExclusion Criteria:\n\n* patients with heart disease or a comorbid illness who have a documented life expectancy of less than 1 year'}, 'identificationModule': {'nctId': 'NCT01248702', 'acronym': 'CAPTURE', 'briefTitle': 'A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy', 'orgStudyIdInfo': {'id': 'H10-01537'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Critical Pathway', 'interventionNames': ['Other: Use of the ICD Critical Pathway']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Practice'}], 'interventions': [{'name': 'Use of the ICD Critical Pathway', 'type': 'OTHER', 'otherNames': ['ICD Critical Pathway'], '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.", 'armGroupLabels': ['Critical Pathway']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'contacts': [{'name': 'S Cowan, MD, MSc', 'role': 'CONTACT', 'email': 'capture.study@gmail.com', 'phone': '(604) 682 2344'}, {'name': 'S Cowan, MD, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'A Ignaszewski, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'C Kerr, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'S Tung, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'S Cowan, MD, MSc', 'role': 'CONTACT', 'email': 'capture.study@gmail.com', 'phone': '(604) 682 2344'}], 'overallOfficials': [{'name': 'S Cowan, MD, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': "St. Paul's Hospital, Vancouver, British Columbia"}, {'name': 'A Ignaszewski, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "St. Paul's Hospital, Vancouver, British Columbia"}, {'name': 'C Kerr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Paul's Hospital, Vancouver, British Columbia"}, {'name': 'S Tung, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "St. Paul's Hospital, Vancouver, British Columbia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}