Pathological Crystallization of Cholesterol in Atherosclerosis

NCT ID: NCT04257942

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-06-30

Brief Summary

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Endarterectomy of the carotid artery procedure will be performed at Sheba Medical center vascular surgery department, followed by fixation and histology. Tissues will then be transferred to Weizmann Institute of Science for observation implementing advanced electron microscopy techniques. Finally, joint evaluation of the results will be carried out, in relation to the patient clinical history.

Detailed Description

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Human atherosclerotic tissues will be obtained from the Department of Vascular Surgery, Sheba Medical Center. Tissues will be taken from donors undergoing routine endarterectomy procedures.We chose carotid artery as the source for the atheromas, due to its high prevalence and its considerable size.All speciemnts will be studied in Cryo-Scanning Electron Microscopy (Cryo-SEM). Tissues will be observed in hydrated vitrified state, after High Pressure Freezing (HPF) and freeze fracture, as well established in the WIS group. Samples will be observed at -120°C. Cathode-Luminescence (CL) detects a luminescence signal induced by electrons in cholesterol crystals and CE condensed states. It will be implemented herein under cryogenic conditions. Sample preparation is as for cryo-SEM. Cryo-FIB-SEM block face serial imaging allows the acquisition of serial images over large volumes (tens of cubed micrometers), at a relatively high imaging resolution (up to 5nm3 voxel size). Volumes of up to 40x40x40 ml will be imaged with a resolution of up to 10nm. The data will be minimally processed and aligned using FIJI, reconstructed and manually segmented using Avizo Lite 9.2.0 software.

Conditions

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Crystallization of Cholesterol in Atherosclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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carotid endarterectomy

carotid endarterctomy that is being used for carotid stenosis disease

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all patients that are being operated on for carotid endarterctomy due to carotid stenosis

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weizmann Institute of Science

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Chen Speter

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Chen Speter

Role: CONTACT

+972 052 6668225

Moshe Halak

Role: CONTACT

+972 052 6666210

Other Identifiers

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SHEBA - 19 - 6467 - MH - CTIL

Identifier Type: -

Identifier Source: org_study_id

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