Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-28 @ 6:50 AM
Study NCT ID:
NCT05862103
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2023-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Follow-Up in Patients With Acute Myocardial Infarction Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of MACCE', 'timeFrame': '5 years after discharge', 'description': 'the incidence of MACCE (death, heart failure, rehospitalization, re-myocardial infarction, re-myocardial revascularization, stroke, malignant arrhythmia, bleeding events, etc.) in AMI patients'}], 'secondaryOutcomes': [{'measure': 'Differences of MACCE between the optimized group and the non-optimized group', 'timeFrame': '5 years after discharge', 'description': 'Differences of the MACCE between the optimized group and the non-optimized group'}, {'measure': 'Differences of the MACCE between OCT-guided group and the coronary angiography -guided group', 'timeFrame': '5 years after discharge', 'description': 'Differences of the MACCE between OCT-guided group and the coronary angiography -guided group'}, {'measure': 'Differences of MACCE between defer PCI group and direct PCI group', 'timeFrame': '3 and 5 years after discharge', 'description': 'Differences of MACCE between defer PCI group and direct PCI group'}, {'measure': 'Differences of the MACCE incidence between cardiac rehabilitation quality improvement group and non-cardiac rehabilitation group', 'timeFrame': '5 years after discharge', 'description': 'Differences of the MACCE incidence between cardiac rehabilitation quality improvement group and non-cardiac rehabilitation group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute myocardial infarction', 'Major adverse cardiac and cerebrovascular event', 'Optimized treatment'], 'conditions': ['Acute Myocardial Infarction', 'Adverse Event']}, 'descriptionModule': {'briefSummary': 'AMI Survivors who participated in the project "Construction and key technology research of the whole myocardial protection system for acute myocardial infarction" (project number 2016YFC1301100) and completed the 1-year visit were followed up by telephone at 3 years (within the corresponding follow-up time window) and 5 years after discharge to acquire the patients\' medication, health status, and major adverse cardiovascular and cerebrovascular events, including death, heart failure, rehospitalization, re-myocardial infarction, revascularization, stroke, malignant arrhythmia, and bleeding events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'AMI survivors who participated in the project "Construction and key technology research on the whole myocardial protection system for acute myocardial infarction" and completed 1-year visit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AMI survivors who participated in the project "Construction and key technology research of the whole myocardial protection system for acute myocardial infarction" and completed the 1-year visit.\n* Telephone to obtain informed consent from the subjects/family members of the subjects.\n\nExclusion Criteria:\n\n* Not available'}, 'identificationModule': {'nctId': 'NCT05862103', 'briefTitle': 'Long-Term Follow-Up in Patients With Acute Myocardial Infarction Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Harbin Medical University'}, 'officialTitle': 'Long-Term Follow-Up in Patients With Acute Myocardial Infarction Cohort - a Prospective, Multicenter Study', 'orgStudyIdInfo': {'id': 'KY2022-266'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'optimized group', 'description': 'the patients received at least one optimized treatment', 'interventionNames': ['Other: Treatment Strategies']}, {'label': 'un-optimized group', 'description': "the patients didn't receive optimized treatment"}], 'interventions': [{'name': 'Treatment Strategies', 'type': 'OTHER', 'description': 'AMI emergency treatment process, pre-reperfusion medication, reperfusion strategy selection, and early cardiac rehabilitation after reperfusion', 'armGroupLabels': ['optimized group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ChunMei Wang', 'role': 'CONTACT', 'email': 'wangchunmei0214@sina.com', 'phone': '13521901670'}], 'facility': 'Beijing An Zhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lefeng Wang', 'role': 'CONTACT', 'email': 'wlf311@sohu.com'}], 'facility': 'Beijing Chao-Yang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianping Li', 'role': 'CONTACT', 'email': 'lijianping@medmail.com.cn'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ning Tan', 'role': 'CONTACT'}], 'facility': 'Guangdong general hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lang Li', 'role': 'CONTACT'}], 'facility': 'The first affiliated hospital of Guangxi medical university', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinshun Gu', 'role': 'CONTACT', 'email': '348220248@qq.com', 'phone': '+8613930139688'}], 'facility': 'Second hospital of hebei medical university', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Daqing', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiqi Sun', 'role': 'CONTACT', 'email': 'zhiqisun6872@hotmail.com', 'phone': '+8613304863433'}], 'facility': 'Daqing Oil Field Hospital', 'geoPoint': {'lat': 46.58333, 'lon': 125.0}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhe Meng', 'role': 'CONTACT', 'phone': '+8618137793359'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Genshan Ma', 'role': 'CONTACT'}], 'facility': 'Zhongda Hospital Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanqing Wu', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '150056', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Liu, MD, PhD', 'role': 'CONTACT', 'email': 'liubin3333@vip.sina.com'}, {'name': 'Bin Liu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Dalian', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Qu', 'role': 'CONTACT'}], 'facility': 'The econd Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Wang', 'role': 'CONTACT', 'phone': '+8615309882359'}, {'name': 'Bin Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "General Hospital of Northern Theater Command of the Chinese People's Liberation Army", 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhijing Zhao', 'role': 'CONTACT', 'email': 'zhaozhj@fmmu.edu.cn', 'phone': '+8613772020951'}], 'facility': 'Xijing Hospital of Air Force Military Medical University', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '400000', 'city': 'Chongqing', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhexue Qin', 'role': 'CONTACT', 'email': 'zhexueqin@126.com', 'phone': '+8615823810730'}, {'name': 'Zhexue Qin, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xinqiao Hospital Army Medical University'}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenjuan Zhang', 'role': 'CONTACT', 'email': 'zwzzyy2013@163.com', 'phone': '+8613002226922'}], 'facility': 'The General Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunjie Li', 'role': 'CONTACT'}, {'name': 'Yin Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chunjie Li', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mei Ma', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Chest Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Ürümqi', 'state': 'Xinjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Ma', 'role': 'CONTACT', 'phone': '+8613669939349'}], 'facility': 'First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}], 'centralContacts': [{'name': 'Xiling Zhang, MD', 'role': 'CONTACT', 'email': 'xlzhangdr@163.com', 'phone': '+86 13804608748'}], 'overallOfficials': [{'name': 'Bo Yu', 'role': 'STUDY_CHAIR', 'affiliation': 'The Second Affiliated Hospital of Harbin Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yu Bo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Yu Bo', 'investigatorAffiliation': 'Harbin Medical University'}}}}