Comparison of LDL Particle Count With Other Available Lipid Tests
LIPID
Comparison of LDL-P With LDLC From VAPII, NMR, and Ion Mobility
1 other identifier
observational
100
1 country
1
Brief 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. 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:
- 1.LDL particle count numbers, as determined by NMR (Liposcience), provides the best estimates of cardiovascular risk.
- 2.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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedNovember 24, 2014
October 1, 2014
8 months
October 27, 2014
November 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Analysis of values will be completed no later than 3 months after enrollment closes.
Eligibility Criteria
Patients who are seen in the outpatient setting
You may qualify if:
- years of age of older
- Can read and write English
You may not qualify if:
- Acute coronary syndrome within 6 months from the time of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scripps Cliniclead
Study Sites (1)
Scripps Center for Integrative Medicine
La Jolla, California, 92037, United States
Biospecimen
Whole blood, serum, and plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas Triffon, MD
Scripps Center for Integrative Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2014
First Posted
November 24, 2014
Study Start
November 1, 2014
Primary Completion
July 1, 2015
Study Completion
August 1, 2016
Last Updated
November 24, 2014
Record last verified: 2014-10