Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-19 @ 6:13 PM
Study NCT ID:
NCT01721369
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2012-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Applicability of Syncope Guidelines in Cataluña
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amoyamitjans@gmail.com', 'title': 'Dr. Angel Moya', 'organization': 'Hospital Vall hebron'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Observational study'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Serious adverse events (SAE) were recollect at 1 year follow up, other adverse events were not recollected in this observational study.', 'eventGroups': [{'id': 'EG000', 'title': 'Transient Loss of Consciousness (T-LOC)', 'description': 'Patient with transient loss of consciousness (T-LOC)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 569, 'seriousNumAffected': 163}], 'seriousEvents': [{'term': 'Life-threatening illness or injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numAffected': 123}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Permanent insufficiency of a body structure or a body function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transient Loss of Consciousness (T-LOC)', 'description': 'Patients with transient loss of consciousness (T-LOC)'}], 'classes': [{'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'To analyze the number of patients that an etiologic diagnose was established according to the New Syncope Guidelines ESC2009 in the hospital care, in a particular community with hospitals with different levels of care in a specific region of Spain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with transient loss of consciousness (T-LOC) from the emergency service and/or external clinic visits (Cardiology, Neurology, etc)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transient Loss of Consciousness (T-LOC)', 'description': 'Patient with transient loss of consciousness (T-LOC)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '581'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '569'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Not initial etiological diagnosis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '581', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Transient Loss of Consciousness (T-LOC)', 'description': 'Patients with transient loss of consciousness (T-LOC)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '214', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '358', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '253', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '328', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '581', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Patients with transient loss of consciousness (T-LOC) from the emergency service and/or external clinic visits (Cardiology, Neurology, etc).'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 581}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2012-06-19', 'resultsFirstSubmitDate': '2018-01-29', 'studyFirstSubmitQcDate': '2012-11-01', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-21', 'studyFirstPostDateStruct': {'date': '2012-11-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009)', 'timeFrame': '12 months', 'description': 'To analyze the number of patients that an etiologic diagnose was established according to the New Syncope Guidelines ESC2009 in the hospital care, in a particular community with hospitals with different levels of care in a specific region of Spain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TLOC'], 'conditions': ['Brief Loss of Consciousness']}, 'descriptionModule': {'briefSummary': 'The aim of SYNCAT study is to study the level of adherence of the centers in Cataluña tu the Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact that following them can have in the prognosis of these patients.', 'detailedDescription': 'The aim of SYNCAT study is to analyze the level of adherence of Syncope Guidelines ESC2009 for the management, diagnosis and treatment of syncope in a specific territory with similar health structure, the region of Cataluña in Spain that includes aprox. 7,000,000 inhabitants, including different complexity level of hospitals and the impact that following guidelines can have in the prognosis of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Transient Loss of Conscience: T-LOC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Each patient that comes from the Emergency room and/or in office doctors visit (Internal Medicine, Cardiology, Neurology...) with Transient Loss of Conscience (T-LOC)\n\nExclusion Criteria:\n\n* Patients younger than 15 years old\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT01721369', 'acronym': 'SYNCAT', 'briefTitle': 'Applicability of Syncope Guidelines in Cataluña', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Observational Study of the Application of the ESC2009 Syncope Guidelines in Cataluña', 'orgStudyIdInfo': {'id': 'SYNCAT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transient Loss of Consciousness (T-LOC)', 'description': 'Transient Loss of Consciousness (T-LOC). Treatment according to normal clinical practice.', 'interventionNames': ['Diagnostic Test: Transient Loss of Consciousness (T-LOC)']}], 'interventions': [{'name': 'Transient Loss of Consciousness (T-LOC)', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['Transient Loss of Consciousness (T-LOC)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Angel Moya, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hospital Vall d'Hebron"}, {'name': 'Jordi Tomàs, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Arnau de Vilanova de Lleida'}, {'name': 'Joan Nicolàs, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parc Sanitari Sant Joan de Déu'}, {'name': 'Jordi Mercè, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Joan XXIII'}, {'name': 'Francesc Planas, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Municipal de Badalona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}