Clinical trial NCT04487223: Characterization of Novel Lipoprotein Properties Associated With an Increased Risk to Develop Atherosclerosis
Official title: Characterization of Novel Lipoprotein Properties Associated With an Increased Risk to Develop Atherosclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

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

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

Primary outcomes:
measure: Characterization of novel lipoprotein properties associated with an increased risk to develop atherosclerosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel HaShomer
country: Israel
facility: Lipid center
Study officials:
References: