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

NCT01543308 | Unknown

• 1 other identifier: 2011-HDL-01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• Differential Proteins and the levels of Differential Proteins

  up to 3 years

Study Arms (2)

coronary heart disease

healthy control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Clinical indication for coronary heart disease and no lipid-lowering therapy in the past 2 weeks

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator
• Beijing Proteome Research Center: collaborator

Study Sites (1)

Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, FuWai Hospital

Beijing, 100037, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

frozen in -80C

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Hong Liu

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Key Laboratory of Clinical Trial Research in Cardiovascular Drugs

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 2, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2015
• Last Updated: May 20, 2013

Record last verified: 2013-05

Locations

CN (1)