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

NCT04487223 | Unknown

• 1 other identifier: 6500-19-SMC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Characterization of novel lipoprotein properties associated with an increased risk to develop atherosclerosis

  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.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will be conducted at the Sheba Medical Center's Lipid Institute, participants will be the Lipid Institute's patients Number of participants: 20 patients with hypercholesterolemia and sclerosis, 20 patients with hypercholesterolemia without evidence of sclerosis, 20 healthy participants as a control group.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Lipid center

Tel Litwinsky, 5265601, Israel

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Tamar Luvish, BSN

CONTACT

972-35303492; tamar.luvish@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 27, 2020
• Study Start: April 27, 2020
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

IL (1)