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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01874691
Other study ID # 2011BAI11B02-A
Secondary ID 2011BAI11B02
Status Completed
Phase
First received
Last updated
Start date January 2013
Est. completion date December 2016

Study information

Verified date May 2022
Source Chinese Academy of Medical Sciences, Fuwai Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study is to build a Chinese national registry and surveillance system for acute myocardial infarction(AMI) to obtain real-world information about current status of characteristics, risk factors, diagnosis, treatment and outcomes of Chinese AMI patients; And to propose scientific precaution strategies aimed to prevent effectively from the incidence of AMI; And to optimize the management and outcomes of AMI patients through implementation of guideline recommendations in clinical practice, and analysis and development of effective treatment strategies; And to create cost-effective assessment system.


Description:

The aim of the study is to establish the national platform for surveillance, clinical research and translational medicine in China, designed to facilitate efforts to improve the quality of AMI patient care and thus decrease morbidity and mortality associated with AMI.


Recruitment information / eligibility

Status Completed
Enrollment 20000
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Eligible patients must be admitted within 7 days of acute ischemic symptoms and diagnosed acute ST-elevation or non ST-elevation myocardial infarction. Diagnosis criteria must meet Universal Definition for AMI (2012). All participating hospitals are required to enroll consecutive patients with AMI. Exclusion Criteria: - Myocardial infarction related to percutaneous coronary intervention and coronary artery bypass grafting.

Study Design


Locations

Country Name City State
China Fuwai Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Peterson ED, Roe MT, Rumsfeld JS, Shaw RE, Brindis RG, Fonarow GC, Cannon CP. A call to ACTION (acute coronary treatment and intervention outcomes network): a national effort to promote timely clinical feedback and support continuous quality improvement for acute myocardial infarction. Circ Cardiovasc Qual Outcomes. 2009 Sep;2(5):491-9. doi: 10.1161/CIRCOUTCOMES.108.847145. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other the in-hospital cost of Chinese patients with acute myocardial infarction the duration of hospital stay, an expected average of 2 weeks
Primary In-hospital mortality of the patients with acute myocardial infarction in different-level hospitals across China Different-level hospitals include Provincial-level, city-level, County-level hospitals from all over China. the duration of hospital stay, an expected average of 2 weeks
Secondary The rate of the application of thrombolysis and primary percutaneous coronary intervention for Chinese patients with acute myocardial infarction in different-level hospitals In different-level hospitals, How many patients with acute myocardial infarction receive thrombolysis and/or primary percutaneous coronary intervention within 24 hours from the onset,respectively? 24 hours
Secondary provoking factors of Chinese patients with AMI across different areas and different population in China The different factors that can provoke the onset of acute myocardial infarction, for example, excess exercise, overload work, heavy smoking, heavy drinking of alcohol and so on. 24 hours
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