Protein and Phospholipid Analysis of HDL in Patients With Very High Serum Levels of HDL-C

This study is currently recruiting participants.
Verified December 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Sergio Fazio, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00525083
First received: September 4, 2007
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

Coronary heart disease (CHD) is the single leading cause of death in the United States . Serum Cholesterol is known to have a direct impact on a number of human diseases through a variety of mechanisms. This is particularly true of cardiovascular disease. Measurement and manipulation of serum cholesterol has become a primary focus of primary care physicians and cardiologists when attempting to reduce risk of heart disease.


Condition
Hyperlipidemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Protein and Phospholipid Analysis of HDL in Patients With Very High Serum Levels of HDL-C

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Identification of protein or phospholipid signature suggestive of dysfunctional HDL [ Time Frame: 2013-2016 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, HDL preps, genomic DNA


Estimated Enrollment: 20
Study Start Date: June 2005
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Clinical investigations have shown that lowering the "total serum cholesterol" levels result in a significant reduction of coronary artery disease and myocardial infarctions . Thus, interventions to lower the "total serum cholesterol" are commonly employed by medical professionals - this includes behavioral modifications (exercise, dieting, and weight loss) and pharmacological interventions.

Investigation has shown that clinical outcomes do not only rely on "total serum cholesterol". "Total serum cholesterol" is comprised of multiple subtypes - most notable are "HDL Cholesterol" and "LDL cholesterol". Analysis of the data has shown that high levels of LDL cholesterol predict higher rates of cardiovascular events, while high levels of HDL cholesterol are actually predictive of significantly less cardiovascular events. These effects are independent of other cardiovascular risk factors .

The mechanism by which LDL cholesterol results in heart disease has been intensely investigated and elucidated. Numerous drugs are now approved and utilized by physicians to lower the LDL cholesterol of patients to prevent primary and secondary cardiovascular disease.

Epidemiological data show that low levels of HDL-C place individuals at higher risk for coronary artery disease while high levels of HDL-C actually decrease an individual's risk . The mechanism behind this risk reduction remains unclear and is likely multi-factorial. Furthermore, some data suggests that while HDL-C is important in risk reduction, it is not necessarily the measured serum level of HDL-C, but also the composition, oxidation state, metabolism of the HDL-C that determines an individual's cardiac risk . Understanding of this mechanism could lead to potential therapeutic targets as well as clinically relevant diagnostic testing.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with HDL above 100 mg/dl and with personal or family history of early atherosclerosis

Criteria

Inclusion Criteria:

  • Age > 18 years.
  • Serum HDL-C > 100 mg/dL.

Exclusion Criteria:

  • Significant history of smoking.
  • Diabetes Mellitus.
  • Severe hypertension.
  • Age > 65 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525083

Contacts
Contact: Sergio Fazio, MD 615-936-1450 sergio.fazio@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Sergio Fazio, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Sergio Fazio, MD, PhD Vanderbilt University
  More Information

No publications provided

Responsible Party: Sergio Fazio, Cornelius Vanderbilt Chair of Cardiovascular Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00525083     History of Changes
Other Study ID Numbers: 050806
Study First Received: September 4, 2007
Last Updated: December 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
hyperlipidemia
HDL-C
low density lipoprotein

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 22, 2014