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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03600259
Other study ID # TAMI20180705
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 1, 2023

Study information

Verified date November 2022
Source Tianjin Chest Hospital
Contact Yin Liu, M.D
Phone +86-13502152283
Email tami2018@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Acute myocardial infarction(AMI) is the most serious manifestation of coronary artery disease. AMI is characterized by high mortality, high disability, and high cost. However, multicenter research on AMI with large sample size in Tianjin or even China is limited. By including AMI in 36 hospitals,this multicenter study will capture the changes in epidemiological trends ,analyze the status of treatment in Tianjin, and explore the best treatment strategies.


Recruitment information / eligibility

Status Recruiting
Enrollment 13000
Est. completion date December 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Hospitalized patients with acute myocardial infarction according to Cardiac biomarker values [Selective cardiac troponin (cTc) elevation and/or decline detection, at least one value exceeds the 99% reference limit (URL) and at least one of the following:(1)Symptoms of myocardial ischemia;(2)New or suspected new obvious ST-T changes or new left bundle branch block (LBBB);(3)ECG pathological Q waves;(4)Image evidence of recent loss of viable myocardium, or new regional wall motion abnormalities;(5)Coronary thrombosis confirmed by angiography or autopsy.] Exclusion Criteria: - Those who did not meet the diagnosis of acute myocardial infarction (no myocardial ischemia-related symptoms, elevation of markers of myocardial necrosis and imaging findings of myocardial infarction); those who met the inclusion criteria but refused to participate in the study; The researchers judged that the subjects had poor compliance and could not Complete follow-up as required.

Study Design


Locations

Country Name City State
China Tianjin Chest Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac death Due to recent cardiac causes (eg myocardial infarction, low-volume heart failure, fatal arrhythmias), any deaths from unknown and unexplained deaths and all surgical-related deaths (including treatment-related deaths) will be attributed to cardiac death.Unless there is a clear non-cardiological cause, all deaths are considered heart disease. Specifically, even patients with concurrent potentially fatal non-cardiac diseases (such as cancer, infections) who have any accidental death should be classified as having a heart attack. 1 year
Secondary Major adverse cardiovascular events Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding 10 days on average (during hospitalization)
Secondary Major adverse cardiovascular events Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding 1 month
Secondary Major adverse cardiovascular events Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding 3 months
Secondary Major adverse cardiovascular events Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding 6 months
Secondary Major adverse cardiovascular events Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding 1 year
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