Characterization of Novel Lipoprotein Properties Associated With an Increased Risk to Develop Atherosclerosis

Sponsor
Sheba Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04487223
Collaborator
(none)
60
1
24
2.5

Study Details

Study Description

Brief Summary

Objectives of Medical Research:

Separation of LDL and HDL from blood samples of patients with high LDL and / or low HDL who have developed atherosclerotic disease with similar patients who have no evidence of atherosclerosis.

Lipidomics and proteomics will examine whether there is a difference in lipid and protein composition and lipoprotein composition. If there are any changes in expression level or the composition of proteins or metabolites that make up lipoproteins, the investigator will try to figure out the mechanism responsible for these changes and their role in the metabolic process. the investigator will seek therapeutic measures through which these mechanisms can be inhibited and thus inhibit the development of sclerosis or even retraction.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Participants:

    Participants who are found suitable during their visit to the Lipid Institute Clinic or during hospitalization at the Sheba Medical Center will receive an explanation of the study, will be asked to sign a consent form.

    A medical history will be taken, the participant will be asked to fill out a nutrition questionnaire (FFQ) and a 5 cc blood sample will be taken from each patient

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Characterization of Novel Lipoprotein Properties Associated With an Increased Risk to Develop Atherosclerosis
    Actual Study Start Date :
    Apr 27, 2020
    Anticipated Primary Completion Date :
    Apr 27, 2022
    Anticipated Study Completion Date :
    Apr 27, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Characterization of novel lipoprotein properties associated with an increased risk to develop atherosclerosis [1 year]

      Lipoproteins would be analyzed by lipidomic and proteomic profiling using chromatography and mass-spectrometry. Concentrations of specific lipids and proteins will be quantified as micrograms per deciliter or as area under the curve. We will look for significant differences in these values between the different study groups using updated software tools specifically designed for mass spectrometry data analysis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy participants with LDL levels less than 130 mg / dl without evidence of atherosclerosis or wall thickening of the carotid artery according to an ultrasound imaging of the carotid artery at the Lipid Institute and unknown for atherosclerosis or cardiovascular disease in the background.

    • Participants with LDL levels above 160 mg / dl, with no evidence of atherosclerosis or wall thickening of the carotid artery according to an ultrasound - IMT of the carotid arteries performed at the Lipid Institute and unknown for atherosclerosis or cardiovascular disease in the background.

    • Participants with LDL levels above 160 mg / dl, where evidence of atherosclerosis or wall thickening of the arteries can be found by ultrasound imaging of the carotid artery that is performed at the Lipid Institute or known for atherosclerosis or cardiovascular disease in the background.

    Exclusion Criteria:
    • Patients with triglyceride values above 300 mg%, HDL lower than 30 mg%, APOB greater than 150 mg% or LPa higher than 70 mg% will not be included in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lipid center Tel HaShomer Israel 5265601

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Rom Keshet, Principal Investigator, Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT04487223
    Other Study ID Numbers:
    • 6500-19-SMC
    First Posted:
    Jul 27, 2020
    Last Update Posted:
    Oct 4, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 4, 2021