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

• ClinicalTrials.gov Identifier: NCT00525083
• Recruitment Status: Terminated
• First Posted: September 5, 2007
• Last Update Posted: April 4, 2017
• Sponsor: Vanderbilt University Medical Center
• 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
• 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

Description:

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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 30, 2017): 19
• Original Estimated Enrollment (submitted: September 4, 2007): 12
• 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

Sex/Gender

• 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

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

Investigators

• Principal Investigator: Sergio Fazio, MD, PhD; Vanderbilt University

• PRS Account: Vanderbilt University Medical Center
• Verification Date: March 2017