Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT01201993
Status:
SUSPENDED
Last Update Posted:
2011-06-21
First Post:
2010-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Laboratory Characteristics of Patients Admitted With Syncope; Diagnosis and Follow up After These Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D013575', 'term': 'Syncope'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-19', 'studyFirstSubmitDate': '2010-08-17', 'studyFirstSubmitQcDate': '2010-09-14', 'lastUpdatePostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnosis', 'timeFrame': '1 year', 'description': 'Final diagnosis as a cause of syncope'}], 'secondaryOutcomes': [{'measure': 'recurrence', 'timeFrame': '6 months', 'description': 'how many patients had recurrence of syncope and average number of syncope in these patients during the period of follow up of each patient.'}, {'measure': 'physical injury', 'timeFrame': '6 months', 'description': 'During this period of follow up of each patient, was there a physical injury, graded either none, mild, moderate or severe (bedridden)'}, {'measure': 'Mental effect', 'timeFrame': '6 months', 'description': 'fear of recurrent syncope affecting his mobility and graded from mild to severe where severe indicates fear of moving even one step without support.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['syncope', 'evaluation', 'recurrence', 'morbidity'], 'conditions': ['Diagnosis', 'Recurrence']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis is that a significant number of patients may remain without specific cause and have recurrent syncope with its associated physical and mental morbidity.', 'detailedDescription': '1. Patients with diagnosis of syncope who were admitted to the medical ward will be interviewed and their charts reviewed to rule in or out the diagnosis of syncope.\n2. Assess physical and mental injury as a result of syncope.\n3. The lab workup will be documented including;\n\n 1. \\- Routine blood tests.\n\n * troponin level.\n 2. \\- ECG.\n\n * Echocardiogram\n * Brain CT.\n * EEG.\n * U/S doppler of carotids.\n * Tilt tests.\n4. At the time of diagnosis the final diagnosis will be documented including recommendations for patients to prevent syncope after discharge.\n5. Follow up after patients by phone verifying recurrence of syncope and resulting physical and or mental injury if any.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Admitted patients the medical ward', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with diagnosis of syncope on admission to the medical ward.\n\nExclusion Criteria:\n\n* patients with loss of consciousness due to other than low perfusion of the brain\n* patients that can't sign a consent form\n* patients that we can't get details about the episode of the syncope"}, 'identificationModule': {'nctId': 'NCT01201993', 'briefTitle': 'Clinical and Laboratory Characteristics of Patients Admitted With Syncope; Diagnosis and Follow up After These Patients', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Observational Study Following After Patients Admitted With Syncope', 'orgStudyIdInfo': {'id': 'SYN2010'}}, 'contactsLocationsModule': {'locations': [{'zip': '34362', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Department of Medicine, Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'George S Habib, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmel Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'George S. Habib', 'oldOrganization': 'Dept of Medicine, Carmel Medical Center'}}}}