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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05862103
Other study ID # KY2022-266
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 20, 2022
Est. completion date December 30, 2026

Study information

Verified date May 2023
Source Harbin Medical University
Contact Xiling Zhang, MD
Phone +86 13804608748
Email xlzhangdr@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15000
Est. completion date December 30, 2026
Est. primary completion date August 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. - Telephone to obtain informed consent from the subjects/family members of the subjects. Exclusion Criteria: - Not available

Study Design


Intervention

Other:
Treatment Strategies
AMI emergency treatment process, pre-reperfusion medication, reperfusion strategy selection, and early cardiac rehabilitation after reperfusion

Locations

Country Name City State
China Beijing An Zhen Hospital, Capital Medical University Beijing Beijing
China Beijing Chao-Yang Hospital, Capital Medical University Beijing Beijing
China Peking Univerisity People'Hospital Beijing Beijing
China Peking University First Hospital Beijing Beijing
China The Second Hospital of Jilin University Changchun Jilin
China Xinqiao Hospital Army Medical University Chongqing Sichuan
China The econd Affiliated Hospital of Dalian Medical University Dalian Liaoning
China Daqing Oil Field Hospital Daqing Heilongjiang
China Guangdong general hospital Guangzhou Guangdong
China The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Zhongda Hospital Southeast University Nanjing Jiangsu
China The first affiliated hospital of Guangxi medical university Nanning Guangxi
China General Hospital of Northern Theater Command of the Chinese People's Liberation Army Shenyang Liaoning
China Second hospital of hebei medical university Shijiazhuang Hebei
China The General Hospital of Tianjin Medical University Tianjin Tianjin
China Tianjin Chest Hospital Tianjing Tianjin
China First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang
China Xijing Hospital of Air Force Military Medical University Xi'an Shanxi
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Yu Bo

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of MACCE the incidence of MACCE (death, heart failure, rehospitalization, re-myocardial infarction, re-myocardial revascularization, stroke, malignant arrhythmia, bleeding events, etc.) in AMI patients 5 years after discharge
Secondary Differences of MACCE between the optimized group and the non-optimized group Differences of the MACCE between the optimized group and the non-optimized group 5 years after discharge
Secondary Differences of the MACCE between OCT-guided group and the coronary angiography -guided group Differences of the MACCE between OCT-guided group and the coronary angiography -guided group 5 years after discharge
Secondary Differences of MACCE between defer PCI group and direct PCI group Differences of MACCE between defer PCI group and direct PCI group 3 and 5 years after discharge
Secondary Differences of the MACCE incidence between cardiac rehabilitation quality improvement group and non-cardiac rehabilitation group Differences of the MACCE incidence between cardiac rehabilitation quality improvement group and non-cardiac rehabilitation group 5 years after discharge
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