- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03600259
Tianjin Inpatient Acute Myocardial Infarction Registry (TAMI)
November 1, 2022 updated by: Yin Liu,MD, Tianjin Chest Hospital
Cohort Study of Acute Myocardial Infarction in Tianjin
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
13000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yin Liu, M.D
- Phone Number: +86-13502152283
- Email: tami2018@163.com
Study Contact Backup
- Name: Jixiang Wang, PHD
- Phone Number: +86-13752068790
- Email: tami2018@163.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300051
- Recruiting
- Tianjin Chest Hospital
-
Contact:
- Yin Liu, M.D.
- Phone Number: +86-13502152283
- Email: tami2018@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hospitalized patients with acute myocardial infarction from 36 hospitals in Tianjin were enrolled between January 2015 and January 2020
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Acute Myocardial Infarction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac death
Time Frame: 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiovascular events
Time Frame: 10 days on average (during hospitalization)
|
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)
|
Major adverse cardiovascular events
Time Frame: 1 month
|
Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding
|
1 month
|
Major adverse cardiovascular events
Time Frame: 3 months
|
Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding
|
3 months
|
Major adverse cardiovascular events
Time Frame: 6 months
|
Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding
|
6 months
|
Major adverse cardiovascular events
Time Frame: 1 year
|
Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yin Liu, M.D, Tianjin Chest Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2018
Primary Completion (ANTICIPATED)
January 1, 2023
Study Completion (ANTICIPATED)
December 1, 2023
Study Registration Dates
First Submitted
July 6, 2018
First Submitted That Met QC Criteria
July 24, 2018
First Posted (ACTUAL)
July 26, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 2, 2022
Last Update Submitted That Met QC Criteria
November 1, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAMI20180705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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