The Alteration of HDL Protein Composition in Patients With Coronary Heart Disease Before and After Statins Treatment

• Conditions: Coronary Heart Disease

• Registration Number: NCT01543308
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

The protein composition of HDL is complicated. The investigators have identified 40 distinct proteins associated with HDL by proteomics technology, and these proteins have been confirmed to be related to the function of anti-inflammation, anti-oxidation, improvement of endothelial function, inhibition of thrombosis and so on. And the investigators also found that the levels of some proteins in HDL changed in patients with coronary heart disease, compared with the healthy control group.

So, this study is to conduct in the two following aspects: enlarge the sample size to verify the preliminary results to find new research ideas of pathogenesis and biomarkers for coronary heart disease; and study the changes of HDL protein composition in patients with coronary heart disease before and after statins treatment using proteomics technology in order to find the mechanism of statins pleiotropic effects and indicators for evaluating the treatment effectiveness.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-03-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-16
• Last Update Posted: 2013-05-20
• Primary Completion: 2013-10
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Angiographic evidence of coronary artery disease, and no lipid-lowering therapy in the past 2 weeks for treatment group;

Exclusion Criteria

• Use of potent lipid-lowering therapy for more than 2 weeks; myocardial infarction or percutaneous coronary intervention in the past 6 months; severe congestive heart failure, valvular heart disease and other non-coronary heart disease cardiovascular disease; liver or renal dysfunction; connective tissue disease; infection, Malignancy; and other conditions that physicians considered inappropriate to the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differential Proteins and the levels of Differential Proteins	up to 3 years

Trial Locations

Locations (1)

Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, FuWai Hospital; 🇨🇳 Beijing, China