Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-01-03 @ 7:18 PM
Study NCT ID:
NCT03510312
Status:
UNKNOWN
Last Update Posted:
2021-03-24
First Post:
2016-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Prognosis in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2016-12-28', 'studyFirstSubmitQcDate': '2018-04-17', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event of Stroke or transient ischemic attack', 'timeFrame': 'through study completion, up to 10 years', 'description': 'The time of a stroke or transient ischemic attack occurs (through study completion)'}, {'measure': 'Event of cardiovascular disease (include stroke/transient ischemic attack)', 'timeFrame': 'through study completion, up to 10 years', 'description': 'The time of a cardiovascular disease (stroke/transient ischemic attack) occurs (through study completion)'}, {'measure': 'All cause mortality', 'timeFrame': 'through study completion, up to 10 years', 'description': 'The time of death from any cause (through study completion)'}, {'measure': 'Cardiovascular cause mortality (include stroke/transient ischemic attack mortality)', 'timeFrame': 'through study completion, up to 10 years', 'description': 'The time of death from cardiovascular cause (through study completion)'}, {'measure': 'The modified Rankin Scale (mRS)', 'timeFrame': '3 months', 'description': 'Measure functional outcome as the form of mRS at 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Stroke']}, 'descriptionModule': {'briefSummary': 'A single-center cohort of patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university and their long-term outcomes.', 'detailedDescription': 'This is a single-center cohort of consecutive patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university in Republic of Korea.\n\nStroke recurrence, Cardiovascular event, all cause mortality and cardiovascular mortality were collected through long-term follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with acute ischemic stroke/transient ischemic attack', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with acute ischemic stroke or transient ischemic attack\n\nExclusion Criteria:\n\n* A patient who did not agree with enrollment of this study'}, 'identificationModule': {'nctId': 'NCT03510312', 'briefTitle': 'Long-term Prognosis in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Severance Hospital'}, 'officialTitle': 'Long-term Prognosis in Stroke Patients', 'orgStudyIdInfo': {'id': '4-2011-0731'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Long-term follow up, observational', 'description': 'This cohort does not involve interventions, just follow up of prognosis of ischemic stroke/transient ischemic attack patients.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ji Hoe Heo, MD, PhD', 'role': 'CONTACT', 'email': 'jhheo@yuhs.ac', 'phone': '82-2-2228-1605'}], 'facility': 'Ji Hoe Heo', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ji Hoe Heo, MD, PhD', 'role': 'CONTACT', 'email': 'jhheo@yuhs.ac', 'phone': '82-2-2228-1605'}], 'overallOfficials': [{'name': 'Ji Hoe Heo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Yonsei University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ji Hoe Heo', 'investigatorAffiliation': 'Severance Hospital'}}}}