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

Coronary Heart Disease Clinical Trial

Official title:

Phase 1 Study of Coronary Heart Disease Proteomics Research

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01543308
• Other study ID #: 2011-HDL-01
• Status: Active, not recruiting
• Phase: N/A
• First received: February 21, 2012
• Last updated: May 16, 2013
• Start date: February 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2013
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, FuWai Hospital	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing Proteome Research Center, Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differential Proteins and the levels of Differential Proteins		up to 3 years	No