HyperlipidemiaLIPIDNCT02298894
Comparison of LDL Particle Count With Other Available Lipid Tests
An observational study of Hyperlipidemia, run by Scripps Clinic at 1 site in United States.
Trial summary
Despite the wide availability of advanced lipoprotein tests, no reference standard exists for Low Density Lipoprotein Cholesterol (LDL-C) due to inherent problems with each of the assays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Aug 2016
- 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 who are seen in the outpatient setting
Who may be able to join
- 18 years of age of older
- Can read and write English
Who cannot join
- Acute coronary syndrome within 6 months from the time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Scripps Center for Integrative Medicine
La Jolla, California, 92037
Eva Stuart, RN, 858-554-3340, Stuart.Eva@scrippshealth.org
Kanae Mukai, MD, 858-554-3330, mukai.kanae@scrippshealth.org
About this study
Official title: Comparison of LDL-P With LDLC From VAPII, NMR, and Ion Mobility
Despite the wide availability of advanced lipoprotein tests, no reference standard exists for Low Density Lipoprotein Cholesterol (LDL-C) due to inherent problems with each of the assays. Newer methods for estimating LDL particle numbers, including nuclear magnetic resonance (NMR) spectroscopy and vertical auto profile (VAP) are currently under investigation. NMR has been proposed as having the best correlation with adverse cardiovascular outcomes. Unfortunately, the accuracy of LDL-C or LDL particle number measurements is currently not monitored by national standardization programs. Direct comparisons between the various testing methods have been limited restricting our ability to accurately interpret and compare values across vendors and lipid parameters.
Our hypothesis is that:
Read more
- LDL particle count numbers, as determined by NMR (Liposcience), provides the best estimates of cardiovascular risk.
- Discrepancies exist between the LDL particle count by NMR and other values as presented by calculated LDLC and directly measured LDL (VAP and ion mobility).
The investigators will enroll 100 patients recruited from the Lipid Clinic at the Scripps Center for Integrative Medicine. Each patient will have one blood draw from which four tests will be analyzed. Risks are associated with drawing blood, which will be minimized by using Scripps Clinic Lab technicians. The potential loss of personal health information will be reduced by limiting access to study and lab staff and keeping information password-protected on Scripps servers.
Read the detailed description
Introduction Advanced lipoprotein testing has been available for over 50 years and its use in cardiovascular risk stratification has been proposed in a number of clinical trials (Superko 2009, 2383). Low Density Lipid Cholesterol (LDLC) is currently used as the key cardiovascular biomarker for assessing risk and monitoring response to lipid therapy (Cole, T. 2013, 752). The highest correlation with cardiovascular risk has been found with apolipoproteinB (apoB) or LDL particle concentration by NMR (Brunzell 2008, 814). Despite the wide availability of advanced lipoprotein tests, no reference standard exists for LDLC due to inherent problems with each of the assays (Mora 2009, 2402)(Marcovina 2006, 440). The most common laboratory method of determining LDLC is by precipitation of apolipoproteinB (apoB) containing lipoprotein particles, measurement of the high density lipoprotein cholesterol (HDLC), and calculation of the LDLC by the Friedewald equation; however, there are inherent errors associated with three separate measurements (Marcovina 2006, Superko 2009, 2384). Correlation between lab LDLC and values obtained by ultracentrifugation has been reported to range from 7 to 31.2%, with a significant amount of misclassification (Marcovina, S. and Packard, C. 2006, 440). Furthermore, elevated triglycerides have been reported to interfere with the accuracy of LDLC measurements (Marcovina, S. and Packard, C. 2006, 440). ApoB, which is the main protein component of LDL, is also considered a direct measure of LDL particle number (Cole, T. 2013, 753). Newer methods for estimating LDL particle number, including NMR and VAP are currently under investigation. NMR has been proposed as having the best correlation with adverse cardiovascular outcomes (reference). Unfortunately, the accuracy of LDLC or LDL particle number measurements is currently not monitored by national standardization programs. Direct comparisons between the various testing methods have been limited limiting our ability to accurately interpret and compare values across vendors and lipid parameters.
Hypothesis:
- LDL particle count numbers determined by NMR (Liposcience) provides the best estimates of cardiovascular risk
- Discrepancies exist between the LDL particle count by NMR and other values:
- Calculated LDLC
- Directly measured LDL (VAP and ion mobility)
Objective:
- To determine the test which has the highest concordance and lowest concordance with the NMR test Study Design
- Prospective analysis with a target study population of 100 patients
- Superiority study aimed to detect a 300 point difference in LDL particle count
- Requires a one-time lab draw for all patients
Inclusion criteria
- Greater than 18 years of age
- On statin, statin and natural supplements, or natural supplements only
Exclusion criteria
- Within 6 months from an acute myocardial infarction (MI) or acute coronary syndrome (ACS)
- Non-English speaker
Risks to the patient:
- Loss of personal health information
- Phlebotomy related risks, including injury, bruising, and vasovagal reactions
- Conditions
- Hyperlipidemia
- Keywords
- Low Density Lipoprotein (LDL), Lipoprotein, Nuclear Magnetic Resonance (NMR), Vertical Auto Profile (VAP), Ion mobility, Apoliproprotein B (ApoB)
- Medical subject headings
- Hyperlipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the Nuclear Magnetic Resonance (NMR) Low Density Lipid (LDL) particle count with LDL values obtained from other methodologies.
Bland Altman plot describing the correlation between LDL particle count number as measured by NMR in comparison to measurements by VAPII, ion mobility, and ApoB liproprotein precipitation will be determined. The specific unit of measurement will be the actual numbers for each LDL particle.
Measured: Analysis of values will be completed no later than 3 months after enrollment closes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015 (estimated)
- Study completionAug 2016 (estimated)
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.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Triffon, MD, Principal investigator, Scripps Center for Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298894
- Sponsor's protocol ID
- SCIML001
- Acronym
- LIPID
- Status last verified
- Oct 2014
- First submitted
- 27 Oct 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of LDL-P With LDLC From VAPII, NMR, and Ion Mobility
- ClinicalTrials.gov ID
- NCT02298894
- Acronym / sponsor ID
- LIPID / SCIML001
- Conditions
- Hyperlipidemia
- Keywords
- Low Density Lipoprotein (LDL), Lipoprotein, Nuclear Magnetic Resonance (NMR), Vertical Auto Profile (VAP), Ion mobility, Apoliproprotein B (ApoB)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Scripps ClinicUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 24 Nov 2014 (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.
Despite the wide availability of advanced lipoprotein tests, no reference standard exists for Low Density Lipoprotein Cholesterol (LDL-C) due to inherent problems with each of the assays. Newer methods for estimating LDL particle numbers, including nuclear magnetic resonance (NMR) spectroscopy and vertical auto profile (VAP) are currently under investigation. NMR has been proposed as having the best correlation with adverse cardiovascular outcomes. Unfortunately, the accuracy of LDL-C or LDL particle number measurements is currently not monitored by national standardization programs. Direct comparisons between the various testing methods have been limited restricting our ability to accurately interpret and compare values across vendors and lipid parameters.
Our hypothesis is that:
- LDL particle count numbers, as determined by NMR (Liposcience), provides the best estimates of cardiovascular risk.
- Discrepancies exist between the LDL particle count by NMR and other values as presented by calculated LDLC and directly measured LDL (VAP and ion mobility).
The investigators will enroll 100 patients recruited from the Lipid Clinic at the Scripps Center for Integrative Medicine. Each patient will have one blood draw from which four tests will be analyzed. Risks are associated with drawing blood, which will be minimized by using Scripps Clinic Lab technicians. The potential loss of personal health information will be reduced by limiting access to study and lab staff and keeping information password-protected on Scripps servers.
Detailed description
Introduction Advanced lipoprotein testing has been available for over 50 years and its use in cardiovascular risk stratification has been proposed in a number of clinical trials (Superko 2009, 2383). Low Density Lipid Cholesterol (LDLC) is currently used as the key cardiovascular biomarker for assessing risk and monitoring response to lipid therapy (Cole, T. 2013, 752). The highest correlation with cardiovascular risk has been found with apolipoproteinB (apoB) or LDL particle concentration by NMR (Brunzell 2008, 814). Despite the wide availability of advanced lipoprotein tests, no reference standard exists for LDLC due to inherent problems with each of the assays (Mora 2009, 2402)(Marcovina 2006, 440). The most common laboratory method of determining LDLC is by precipitation of apolipoproteinB (apoB) containing lipoprotein particles, measurement of the high density lipoprotein cholesterol (HDLC), and calculation of the LDLC by the Friedewald equation; however, there are inherent errors associated with three separate measurements (Marcovina 2006, Superko 2009, 2384). Correlation between lab LDLC and values obtained by ultracentrifugation has been reported to range from 7 to 31.2%, with a significant amount of misclassification (Marcovina, S. and Packard, C. 2006, 440). Furthermore, elevated triglycerides have been reported to interfere with the accuracy of LDLC measurements (Marcovina, S. and Packard, C. 2006, 440). ApoB, which is the main protein component of LDL, is also considered a direct measure of LDL particle number (Cole, T. 2013, 753). Newer methods for estimating LDL particle number, including NMR and VAP are currently under investigation. NMR has been proposed as having the best correlation with adverse cardiovascular outcomes (reference). Unfortunately, the accuracy of LDLC or LDL particle number measurements is currently not monitored by national standardization programs. Direct comparisons between the various testing methods have been limited limiting our ability to accurately interpret and compare values across vendors and lipid parameters.
Hypothesis:
- LDL particle count numbers determined by NMR (Liposcience) provides the best estimates of cardiovascular risk
- Discrepancies exist between the LDL particle count by NMR and other values:
- Calculated LDLC
- Directly measured LDL (VAP and ion mobility)
Objective:
- To determine the test which has the highest concordance and lowest concordance with the NMR test Study Design
- Prospective analysis with a target study population of 100 patients
- Superiority study aimed to detect a 300 point difference in LDL particle count
- Requires a one-time lab draw for all patients
Inclusion criteria
- Greater than 18 years of age
- On statin, statin and natural supplements, or natural supplements only
Exclusion criteria
- Within 6 months from an acute myocardial infarction (MI) or acute coronary syndrome (ACS)
- Non-English speaker
Risks to the patient:
- Loss of personal health information
- Phlebotomy related risks, including injury, bruising, and vasovagal reactions
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are seen in the outpatient setting
Key inclusion criteria (2 listed)
- 18 years of age of older
- Can read and write English
Key exclusion criteria (1 listed)
- Acute coronary syndrome within 6 months from the time of enrollment
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
Comparing the Nuclear Magnetic Resonance (NMR) Low Density Lipid (LDL) particle count with LDL values obtained from other methodologies.
Time frame: Analysis of values will be completed no later than 3 months after enrollment closes.
Bland Altman plot describing the correlation between LDL particle count number as measured by NMR in comparison to measurements by VAPII, ion mobility, and ApoB liproprotein precipitation will be determined. The specific unit of measurement will be the actual numbers for each LDL particle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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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.
Douglas Triffon, MD principal investigator
Scripps Center for Integrative Medicine
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 Scripps Clinic 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 1 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: status not confirmed, as of the sponsor's last update on 24 Nov 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Stuart, RN (858-554-3340, stuart.eva@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the Nuclear Magnetic Resonance (NMR) Low Density Lipid (LDL) particle count with LDL values obtained from other methodologies. (time frame: Analysis of values will be completed no later than 3 months after enrollment closes.). 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 24 Nov 2014.