Recruiting

Lipid Tests

Sponsor:

Scripps Clinic

Code:

NCT02298894

Conditions

Hyperlipidemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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).

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.

Conditions

Hyperlipidemia

Study ID

NCT02298894

Start date

Nov, 2014

Status verified date

Oct, 2014

Completion date

Aug, 2016

Anticipated

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age of older
  • Can read and write English

Exclusion Criteria:

  • Acute coronary syndrome within 6 months from the time of enrollment

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

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. ]

Central Contacts and Locations

Locations

Scripps Center for Integrative Medicine

Recruiting

La Jolla, California, United States, 92037

Contacts

Principal Investigator:

Douglas Triffon, MD

More Information

Sponsor

Scripps Clinic

Last update posted

Nov 24, 2014

Last verified

Oct, 2014

Keywords

  • Low Density Lipoprotein (LDL)
  • Lipoprotein
  • Nuclear Magnetic Resonance (NMR)
  • Vertical Auto Profile (VAP)
  • Ion mobility
  • Apoliproprotein B (ApoB)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Clinic on 2014-11-24.