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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ministry of Science and Technology of the People´s Republic of China
Beijing Proteome Research Center
Information provided by (Responsible Party):
Yan Li-rong, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01543308
First received: February 21, 2012
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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.


Condition
Coronary Heart Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Phase 1 Study of Coronary Heart Disease Proteomics Research

Resource links provided by NLM:


Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • Differential Proteins and the levels of Differential Proteins [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

frozen in -80C


Estimated Enrollment: 400
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
coronary heart disease
healthy control group

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01543308

Locations
China
Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, FuWai Hospital
Beijing, China, 100037
Sponsors and Collaborators
Cardiovascular Institute & Fuwai Hospital
Ministry of Science and Technology of the People´s Republic of China
Beijing Proteome Research Center
Investigators
Principal Investigator: Hong Liu FuWai Hospital
  More Information

No publications provided

Responsible Party: Yan Li-rong, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01543308     History of Changes
Other Study ID Numbers: 2011-HDL-01
Study First Received: February 21, 2012
Last Updated: May 16, 2013
Health Authority: China: Ministry of Science and Technology

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014