Clinical trial NCT00525083: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hyperlipidemia
Keywords: hyperlipidemia
HDL-C
low density lipoprotein
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2007-09-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HDL above 100 mg/dl and with personal or family history of early atherosclerosis

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.

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

Primary outcomes:
measure: Identification of protein or phospholipid signature suggestive of dysfunctional HDL
timeFrame: 2013-2016
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Sergio Fazio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: