Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-26 @ 5:10 PM
Study NCT ID:
NCT05450757
Status:
UNKNOWN
Last Update Posted:
2022-07-11
First Post:
2022-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shanghai ST-segment Elevation Myocardial Infarction Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples at the time of pre-PCI, post-PCI, post-PCI 1 day, post-PCI 3days'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-09-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-06', 'studyFirstSubmitDate': '2022-07-02', 'studyFirstSubmitQcDate': '2022-07-06', 'lastUpdatePostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Synchronized analysis of phonocardiogram and electrocardiogram', 'timeFrame': '1 day, 1 month, 6 months, 1 year', 'description': 'Synchronized PCG and ECG data using a wearable cardiac monitoring patch'}], 'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': '0-1 year', 'description': 'Major adverse cardiovascular events(MACE) in one year follow-up'}, {'measure': 'Left Ventricular Function', 'timeFrame': '1 month, 6month and 1 year', 'description': 'Left ventricular end diastolic volume(LVEDV),Left ventricular end systolic volume(LVESE),Left ventricular ejection fraction(LVEF) changes within one year follow-up'}, {'measure': 'Coronary angiography', 'timeFrame': '1 year', 'description': 'The pathological changes in culprit vessels in 1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Myocardial Infarction', 'Cardiac Remodelling', 'Heart Failure'], 'conditions': ['ST Elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'ST-segment elevation myocardial infarction(STEMI) remains a major cause of morbidity and mortality worldwide, despite of the early reperfusion therapy, including fibrinolysis, primary percutaneous coronary intervention (PCI),and standardized medical treatment.To improve the prognosis of STEMI patients, the management in their hospitalization should be optimized, including improvements in risk stratification, more widespread use of an invasive strategy, implementation of care delivery systems prioritising immediate revascularisation through PCI (or fibrinolysis), advances in antiplatelet agents and anticoagulants, and greater use of secondary prevention strategies such as lipid-lowering therapy.\n\nThis study aims to standardized the management of STEMI patients and improve the prognosis of the STEMI patients.', 'detailedDescription': 'This study is a prospective cohort study. It aims to standardized the management of STEMI patients and improve the prognosis of the STEMI patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "This is multi-center cohort study. Patients with acute ST elevation myocardial infarction undergo percutaneous coronary intervention within 12 hours of symptom onset at Ruijin Hospital, Minhang district Center Hospital, Yangpu district Center Hospital, Putuo district Center hospital,Jiading district Center Hospital, Fengxian district Center Hospital,and Shanghai Fifth people's Hospital, Shanghai, China are consecutively enrolled.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ST elevation myocardial infarction\n* Coronary angiography and percutaneous coronary intervention within 12 hours of symptom onset\n* Capable and willing to provide informed conset and capable of completing study visits\n\nExclusion Criteria:\n\n* Cardiovascular shock at admission\n* Severe physical disability\n* Active malignant tumors\n* Active autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT05450757', 'briefTitle': 'Shanghai ST-segment Elevation Myocardial Infarction Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'A Prospective Multicentre Cohort Study of Acute ST-segment Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'RJH-STEMI'}}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuo Feng, M.D., Ph.D.', 'role': 'CONTACT'}], 'facility': 'Ruijin hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Zhang, M.D.', 'role': 'CONTACT'}], 'facility': 'Shanghai Fengxian District Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Qiao, M.D.', 'role': 'CONTACT'}], 'facility': "Shanghai Fifth People's Hospital, Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunya Zhang, M.D.', 'role': 'CONTACT'}], 'facility': 'Shanghai Jiading District Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Dong, M.D.', 'role': 'CONTACT'}], 'facility': 'Shanghai Minhang District Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Youlong Xu, M.D.', 'role': 'CONTACT'}], 'facility': 'Shanghai Putuo District Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qunlin Gong, M.D.', 'role': 'CONTACT'}], 'facility': 'Shanghai Yangpu District Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shuo Feng, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'fengshuorv@hotmail.com', 'phone': '+86 15921388296'}], 'overallOfficials': [{'name': 'Wei Wei Quan, M.D.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Tian Qi Zhu, M.D.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Xiao Xiang Yan, M.D.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Wen Li Zhang, M.D.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Run Du, M.D.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Ying Jia Xu, M.D.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}, {'name': 'Wei Hu', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Minhang District Central Hospital'}, {'name': 'Yimeng Zhou', 'role': 'STUDY_CHAIR', 'affiliation': 'Tongji University'}, {'name': 'Zongjun Liu', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Putuo District Central Hospital'}, {'name': 'Xiangdong Xu', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Jiading District Central Hospital'}, {'name': 'Zengyong Qiao', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Fengxian District Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cardiology Department, Chief Physician', 'investigatorFullName': 'RUIYAN ZHANG', 'investigatorAffiliation': 'Ruijin Hospital'}}}}