HyperlipidemiaNCT00525083
Protein and Phospholipid Analysis of HDL in Patients With Very High Serum Levels of HDL-C
An observational study of Hyperlipidemia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to 3 Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HDL above 100 mg/dl and with personal or family history of early atherosclerosis
Who may be able to join
- Age > 18 years.
- Serum HDL-C > 100 mg/dL.
Who cannot join
- Significant history of smoking.
- Diabetes Mellitus.
- Severe hypertension.
- Age > 65 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the 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.
- Conditions
- Hyperlipidemia
- Keywords
- hyperlipidemia, HDL-C, low density lipoprotein
- Medical subject headings
- Hyperlipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of protein or phospholipid signature suggestive of dysfunctional HDL
Measured: 2013-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startJun 2005
- Primary completion3 Nov 2014
- Study completion3 Nov 2014
Why it stopped: PI left for another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio Fazio, MD, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525083
- Sponsor's protocol ID
- 050806
- Status last verified
- Mar 2017
- First submitted
- 4 Sep 2007
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein and Phospholipid Analysis of HDL in Patients With Very High Serum Levels of HDL-C
- ClinicalTrials.gov ID
- NCT00525083
- Acronym / sponsor ID
- 050806
- Conditions
- Hyperlipidemia
- Keywords
- hyperlipidemia, HDL-C, low density lipoprotein
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left for another institution
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jun 2005 (actual)
- Primary completion
- 3 Nov 2014 (actual)
- Study completion
- 3 Nov 2014 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HDL above 100 mg/dl and with personal or family history of early atherosclerosis
Key inclusion criteria (2 listed)
- Age > 18 years.
- Serum HDL-C > 100 mg/dL.
Key exclusion criteria (4 listed)
- Significant history of smoking.
- Diabetes Mellitus.
- Severe hypertension.
- Age > 65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of protein or phospholipid signature suggestive of dysfunctional HDL
Time frame: 2013-2016
Results and safety
The study was stopped early (reason given: PI left for another institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Fazio, MD, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemia, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left for another institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of protein or phospholipid signature suggestive of dysfunctional HDL (time frame: 2013-2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.