Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-27 @ 11:17 AM
Study NCT ID:
NCT02587494
Status:
UNKNOWN
Last Update Posted:
2017-08-23
First Post:
2015-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Catheterization in Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006328', 'term': 'Cardiac Catheterization'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-22', 'studyFirstSubmitDate': '2015-08-27', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': '30 day'}, {'measure': 'CPC score', 'timeFrame': 'up to 30 days'}, {'measure': 'Acute kidney injury- creatinine levels', 'timeFrame': '48 hours', 'description': 'Number of participants with increase in serum creatinine of ≥44.2 μmol/L, or a 25% relative rise in creatinine, within 48 h after contrast exposure42'}, {'measure': 'Myocardial infarction - according to cardiac troponin levels', 'timeFrame': '30 days', 'description': 'Number of participants with myocardial infarction post percutaneous coronary interventions, in accordance with the universal definition of myocardial infarction.'}, {'measure': 'Stent thrombosis by pathology or angiography', 'timeFrame': '30 days', 'description': 'Number of participants with definite stent thrombosis confirmed by angiography or pathology according to the Academic research consortium criteria'}, {'measure': 'Bleeding - according to Hb levels', 'timeFrame': '30 days', 'description': 'Number of participant with overt bleeding according to Academic Research Consortium criteria'}, {'measure': 'Composite of death and poor neurologic outcome', 'timeFrame': '1 year'}, {'measure': 'Stroke - imaging or pathology', 'timeFrame': '30 days', 'description': 'New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)'}, {'measure': 'Heart failure (NYHA 3-4)', 'timeFrame': '30 days'}, {'measure': 'Estimated cost per patient according to length of stay and procedures performed', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Out of Hospital Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'This is a pilot study that will lead to a large randomized control trial (RCT), to assess whether early versus late or no cardiac catheterization is associated with improved outcomes in out-of-hospital cardiac arrest (OHCA) patients.', 'detailedDescription': 'A pilot multicenter RCT.\n\nThe objectives of the study are:\n\nTo assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in OHCA patients.\n\nPatients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (ROSC) following OHCA, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. Percutaneous coronary intervention (PCI) is recommended for culprit lesions found on diagnostic angiography. All patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°C according to local practice. Other medical management will be according to standard of care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Glasgow Coma Scale score \\<8 on hospital admission following OHCA of presumed cardiac cause.\n* Initial rhythm ventricular tachycardia (VT) / ventricular fibrillation (VF), who achieved ROSC sustained for \\>20 consecutive minutes\n\nExclusion Criteria:\n\n* ST-elevation on any of the ECGs post resuscitation\n* Hypothermia \\<30°C\n* Interval from ROSC to screening of \\>12h\n* Suspected or known acute intracranial hemorrhage or stroke'}, 'identificationModule': {'nctId': 'NCT02587494', 'briefTitle': 'Cardiac Catheterization in Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Role of Early Cardiac Catheterization in Cardiac Arrest', 'orgStudyIdInfo': {'id': '106834'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early cardiac catheterization', 'description': 'Cardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia', 'interventionNames': ['Procedure: Cardiac catheterization']}, {'type': 'NO_INTERVENTION', 'label': 'Medical arm', 'description': 'Initial therapy does not include cardiac catheterization. Cardiac catheterization with possible PCI is allowed after completion of mild therapeutic hypothermia or apyrexia for \\>24h post ROSC.'}], 'interventions': [{'name': 'Cardiac catheterization', 'type': 'PROCEDURE', 'otherNames': ['Coronary angiography'], 'description': 'Cardiac catheterization / coronary angiography is a diagnostic procedure used to define the coronary anatomy and presence of obstructive coronary lesions or culprit lesions. According to the findings, it may lead to percutaneous coronary intervention (PCI) using stents', 'armGroupLabels': ['Early cardiac catheterization']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Shahar Lavi, MD', 'role': 'CONTACT', 'email': 'shahar.lavi@lhsc.on.ca', 'phone': '519-663-3611'}, {'name': 'Mistre Alemayehu, MSc', 'role': 'CONTACT', 'email': 'mistre.alemayehu@lhsc.on.ca', 'phone': '519-685-8500', 'phoneExt': '35625'}, {'name': 'Shahar Lavi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'centralContacts': [{'name': 'Shahar Lavi, MD', 'role': 'CONTACT', 'email': 'shahar.lavi@lhsc.on.ca', 'phone': '519-6633611'}, {'name': 'Mistre Alemayehu', 'role': 'CONTACT', 'email': 'mistre.alemayehu@lhsc.on.ca', 'phone': '519-6633611'}], 'overallOfficials': [{'name': 'Shahar Lavi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shahar Lavi', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}