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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05121818
Other study ID # ZSMI21
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2026

Study information

Verified date November 2021
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In order to accelerate border crossing between basic research and clinical research in acute myocardial infarction, it is necessary to easily use clinical and biological data. That is the reason why it is very important to create a clinical, biological and pathologic database of acute myocardial infarction, mainly prospective. All data are from patients treated in 5 centers in Shanghai,including Zhongshan Hospital of Fudan University, Shanghai Renji Hospital,Shanghai Tenth People's Hospital,Shanghai First People's Hospital, and Shanghai Tongji Hospital.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3000
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Acute myocardial infarction was diagnosed based on the Fourth Universal Definition of Acute myocardial infarction criteria. The term acute myocardial infarction should be used when there is acute myocardial injury with clinical evidence of acute myocardial ischaemia and with detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL and at least one of the following: Symptoms of myocardial ischaemia; New ischaemic ECG changes; Development of pathological Q waves; Imaging evidence of new loss of viable myocardium or new regional wallmotion abnormality in a pattern consistent with an ischaemic aetiology; Identification of a coronary thrombus by angiography or autopsy. Exclusion Criteria: - life expectancy of less than 12 months - malignant tumor - pregnancy or plans of pregnancy in the one year - any anticoagulation therapy such as heparin within 24 hours of baseline blood sampling

Study Design


Intervention

Procedure:
PCI
Primary percutaneous coronary intervention

Locations

Country Name City State
China Zhongshan Hospital Shanghai Shanghai

Sponsors (5)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital RenJi Hospital, Shanghai 10th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Tongji Hospital, Tongji University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Database of patients with acute myocardial infarction 5 years
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