Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-05 @ 6:07 PM
Study NCT ID:
NCT03763968
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2018-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicentre REtrospective StuDy of Treatment and OUtComes in STEMI Patients in Fujian Province
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016896', 'term': 'Treatment Outcome'}], 'ancestors': [{'id': 'D011379', 'term': 'Prognosis'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-01', 'studyFirstSubmitDate': '2018-11-30', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': '5years', 'description': 'all mortality,cardiovascular mortality'}], 'secondaryOutcomes': [{'measure': 'other in-hospital complications', 'timeFrame': '5years', 'description': 'recurrent myocardial infarction, target vessel revascularization,contrast-induced acute kidney injury,stroke,bleeding,and so on'}, {'measure': 'MACEs for long-term follow up', 'timeFrame': '1 year', 'description': 'mortality,stent restenosis, recurrent myocardial infarction, and target vessel revascularization,stroke,bleeding,and so on'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ST-segment Elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'This is a multicentre observational study planned to gather follow up data for a period of 1 year in order to understand the treatments and outcomes of ST-segment elevation myocardial infarction(STEMI) and improve medical care quality in Fujian province for China. Consecutive patients who were admitted and diagnosed with STEMI between January 2014 December 2018 were conducted at five regional representative hospitals in Fujian province, which included the Fujian Provincial Hospital,Longyan First Hospital, the affiliated hospital of putian university,the Second Affiliated Hospital of Fujian Medical University and Mindong Hospital of Ningde City.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'STEMI patients with symptom onset within 30 days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* STEMI patients with symptom onset within 30 days\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03763968', 'acronym': 'REDUCTION', 'briefTitle': 'Multicentre REtrospective StuDy of Treatment and OUtComes in STEMI Patients in Fujian Province', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Provincial Hospital'}, 'officialTitle': 'Multicentre REtrospective StuDy of Treatment and OUtComes in ST-elevatION Myocardial Infarction(STEMI) Patients in Fujian Province', 'orgStudyIdInfo': {'id': 'YGuo'}}, 'armsInterventionsModule': {'interventions': [{'name': 'treatment and outcome', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Provincial', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'overallOfficials': [{'name': 'Kai-yang Lin, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Provincial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yan-song Guo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Longyan City First Hospital', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Putian University', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': 'The MinDong Hospital of Ningde City', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Fujian Provincial Hospital', 'investigatorFullName': 'Yan-song Guo', 'investigatorAffiliation': 'Fujian Provincial Hospital'}}}}