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Clinical Trials/NCT04487223
NCT04487223
Unknown
Not Applicable

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

Sheba Medical Center1 site in 1 country60 target enrollmentApril 27, 2020
ConditionsAtherosclerosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atherosclerosis
Sponsor
Sheba Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Characterization of novel lipoprotein properties associated with an increased risk to develop atherosclerosis
Last Updated
4 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
April 27, 2020
End Date
April 27, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Rom Keshet

Principal Investigator

Sheba Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Study Sites (1)

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