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NCT02641184 Clinical Trial

Evaluation of Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction

Coronary Artery Disease Clinical Trial

Official title:
A Multicenter Prospective Observational Study to Evaluate the Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction (AMI)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02641184
Other study ID # ZJPPH01
Secondary ID
Status Enrolling by invitation
Phase N/A
First received December 14, 2015
Last updated February 13, 2016
Start date December 2015

Study information
Verified date February 2016
Source Zhejiang Provincial People’s Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

The aim of this study is to investigate the potential novel risk factors for acute myocardial infarction. Predictors of poor outcomes will be also evaluated.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 3000
Est. completion date
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Less than 12 hours after the onset of myocardial infarction symptoms

- Myocardial necrosis, as evidenced by increased Creatine Kinase Isoenzyme (CK-MB) or troponin levels

Exclusion Criteria:

- Age under 18 years-old

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Zhejiang provincial people's hospital Hangzhou Zhejiang

Sponsors (4)
Lead Sponsor Collaborator
Zhejiang Provincial People’s Hospital Huaian first people's hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Yangzhou No.1 People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major adverse cardiovascular events (MACE) Composite of angina pectoris, reinfarction, unplanned rehospitalization, stent thrombosis, incidence of cardiac death in the duration of follow-up maximum 5 years No
Secondary Length of hospital stay The length of in-hospital stay is counted as a secondary outcome in the phase of hospital stay, maximum 30 days No
Secondary New-onset diabetes New-onset diabetes are defined as newly-diagnosed type 2 diabetes mellitus the duration of follow-up, maximum 5 years No
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