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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00525083
Recruitment Status : Terminated (PI left for another institution)
First Posted : September 5, 2007
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):
Vanderbilt University Medical Center

Tracking Information
First Submitted Date September 4, 2007
First Posted Date September 5, 2007
Last Update Posted Date April 4, 2017
Actual Study Start Date June 2005
Actual Primary Completion Date November 3, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 24, 2013)
Identification of protein or phospholipid signature suggestive of dysfunctional HDL [ Time Frame: 2013-2016 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Protein and Phospholipid Analysis of HDL in Patients With Very High Serum Levels of HDL-C
Official Title Protein and Phospholipid Analysis of HDL in Patients With Very High Serum Levels of HDL-C
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Plasma, HDL preps, genomic DNA
Sampling Method Non-Probability Sample
Study Population Patients with HDL above 100 mg/dl and with personal or family history of early atherosclerosis
Condition Hyperlipidemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 30, 2017)
Original Estimated Enrollment
 (submitted: September 4, 2007)
Actual Study Completion Date November 3, 2014
Actual Primary Completion Date November 3, 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT00525083
Other Study ID Numbers 050806
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Vanderbilt University Medical Center
Study Sponsor Vanderbilt University Medical Center
Collaborators Not Provided
Principal Investigator: Sergio Fazio, MD, PhD Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date March 2017