Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-27 @ 5:23 PM
Study NCT ID:
NCT04972058
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Philippine Neurological Association One Database - Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D020767', 'term': 'Intracranial Thrombosis'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002542', 'term': 'Intracranial Embolism and Thrombosis'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14800}, 'targetDuration': '10 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-20', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital caseload', 'timeFrame': '3 years', 'description': 'Number of TIA and stroke cases admitted in participating sites.'}], 'secondaryOutcomes': [{'measure': 'In-hospital diagnostic procedure (brain scan)', 'timeFrame': 'From admission to discharge, may be up to 1 month', 'description': 'Rate of performance of brain scan.'}, {'measure': 'In-hospital diagnostic procedures (electrocardiogram)', 'timeFrame': 'From admission to discharge, may be up to 1 month', 'description': 'Rate of performance of electrocardiogram.'}, {'measure': 'In-hospital diagnostic procedures (echocardiogram)', 'timeFrame': 'From admission to discharge, may be up to 1 month', 'description': 'Rate of performance of echocardiogram.'}, {'measure': 'In-hospital diagnostic procedures (cerebral vascular studies)', 'timeFrame': 'From admission to discharge, may be up to 1 month', 'description': 'Rate of performance of any cerebral vascular study.'}, {'measure': 'In-hospital therapeutic management (thrombolysis)', 'timeFrame': 'From admission to discharge, may be up to 1 month', 'description': 'Rate of treatment with thrombolysis (intravenous and/or endovascular).'}, {'measure': 'In-hospital therapeutic management (anti-thrombotics)', 'timeFrame': 'From admission to discharge, may be up to 1 month', 'description': 'Rate of treatment with any anti-thrombotic (anti-platelet and/or anti-coagulant).'}, {'measure': 'In-hospital therapeutic management (rehabilitation)', 'timeFrame': 'From admission to discharge, may be up to 1 month', 'description': 'Rate of rehabilitation (physical therapy and/or occupational therapy and or speech therapy).'}, {'measure': 'In-hospital complications from TIA or stroke', 'timeFrame': 'From admission to discharge, may be up to 1 month', 'description': 'Rate of complications arising from TIA or stroke.'}, {'measure': 'Vital status at hospital discharge', 'timeFrame': 'At discharge, may be up to 1 month', 'description': 'Alive or dead'}, {'measure': 'Functional status at hospital discharge', 'timeFrame': 'At discharge, may be up to 1 month', 'description': 'modified Rankin Scale'}, {'measure': 'Neurological status at hospital discharge', 'timeFrame': 'At discharge, may be up to 1 month', 'description': 'National Institute of Health Stroke Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transient Ischemic Attack', 'Ischemic Stroke', 'Intracerebral Hemorrhage', 'Subarachnoid Hemorrhage', 'Cerebral Venous Thrombosis']}, 'referencesModule': {'references': [{'pmid': '35613760', 'type': 'DERIVED', 'citation': 'Philippine Neurological Association One Database - Stroke, Disease Study Management Group. Multicentre collection of uniform data on patients hospitalised for transient ischaemic attack or stroke in the Philippines: the Philippine Neurological Association One Database-Stroke (PNA1DB-Stroke) protocol. BMJ Open. 2022 May 24;12(5):e055954. doi: 10.1136/bmjopen-2021-055954.'}]}, 'descriptionModule': {'briefSummary': 'This is a pragmatic, multi-center, prospective, observational, non-interventional study and standing database of patients hospitalized for transient ischemic attack (TIA) or stroke in the 11 accredited adult neurology training institutions in the Philippines. Data will be collected from each patient while admitted in the hospital and until hospital discharge. Data collection for this study will span 3 years from study initiation, after which the utility of an extension or a re-implementation of the study will be assessed.', 'detailedDescription': 'Primary objective is to prospectively collect data on demographics, medical history, in-hospital management, and outcomes among patients with first or recurrent TIA or ischemic or hemorrhagic stroke admitted in accredited adult neurology training institutions in the Philippines.\n\nSecondary objectives are:\n\n1. To determine the in-patient case load of first and recurrent TIA and stroke.\n2. To determine the profile of patients admitted for first or recurrent TIA or stroke.\n3. To determine the types of diagnostic and therapeutic management received by patients with first or recurrent TIA or stroke.\n4. To determine the outcomes of patients with first or recurrent TIA or stroke at the time of hospital discharge.\n5. To evaluate factors that predict outcome among patients with first or recurrent TIA or stroke.\n6. To assess and audit the overall quality of care received by patients admitted for first or recurrent TIA or stroke.\n7. To perform other future analyses, sanctioned by the Philippine Neurological Association (PNA), that may improve knowledge on the care of patients with first and/or recurrent TIA or stroke.\n\nAll eligible patients will be assigned a study identification (ID) number and included in the site log kept confidentially in each site. Corresponding anonymized data on demographics, medical history, stroke sub-type, in-hospital management and discharge outcomes will be collected from each patient and entered in the database using a secure online data collection tool.\n\nCollective data will be extracted, summarized, and analyzed for the secondary objectives every year with oversight provided by the Philippine Neurological Association.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted at the participating sites fulfilling all inclusion and none of the exclusion criteria are eligible to be included.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of first or recurrent TIA, ischemic or hemorrhagic stroke, or cerebral venous thrombosis (CVT)\n2. 18 years old or older\n3. Admitted in the participating hospital\n4. If required by the institutional review board/ethics committee, signed or verbal informed consent for participation in the study from the patient or a legal representative\n\nExclusion Criteria:\n\n1. Patients with previous TIA or stroke who are admitted to the hospital for medical conditions other than an acute stroke, e.g., patient with non-acute stroke admitted for pneumonia, rehabilitation, or procedures, such as gastric tube insertion, etc.\n2. Any condition which, in the study investigator's opinion, may jeopardize the patient by his/her participation in this study or affect the validity of the study results"}, 'identificationModule': {'nctId': 'NCT04972058', 'acronym': 'PNA1DB-Stroke', 'briefTitle': 'Philippine Neurological Association One Database - Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Philippine Neurological Association'}, 'officialTitle': 'Philippine Neurological Association One Database - Stroke', 'orgStudyIdInfo': {'id': 'PNA1DB-Stroke'}}, 'contactsLocationsModule': {'locations': [{'city': 'Baguio City', 'state': 'Benguet', 'country': 'Philippines', 'facility': 'Baguio General Hospital and Medical Center', 'geoPoint': {'lat': 16.41639, 'lon': 120.59306}}, {'city': 'Cebu City', 'country': 'Philippines', 'facility': 'Chong Hua Hospital', 'geoPoint': {'lat': 10.31672, 'lon': 123.89071}}, {'city': 'Makati City', 'country': 'Philippines', 'facility': 'Makati Medical Center', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'Jose R. Reyes Memorial Medical Center', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'University of Santo Tomas Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'University of the Philippines - Philippine General Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Pasig', 'country': 'Philippines', 'facility': 'The Medical City', 'geoPoint': {'lat': 14.58691, 'lon': 121.0614}}, {'city': 'Quezon City', 'country': 'Philippines', 'facility': 'East Avenue Medical Center', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'country': 'Philippines', 'facility': 'Quirino Memorial Medical Center', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'country': 'Philippines', 'facility': "St. Luke's Medical Center (QC, BGC)", 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'country': 'Philippines', 'facility': 'University of the East - Ramon Magsaysay Memorial Medical Center', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}], 'overallOfficials': [{'name': 'Robert N Gan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Philippine Neurological Association'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philippine Neurological Association', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}