Pathological Crystallization of Cholesterol in Atherosclerosis

Crystallization of Cholesterol in Atherosclerosis Clinical Trial

Official title:

Pathological Crystallization of Cholesterol in Atherosclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04257942
• Other study ID #: SHEBA - 19 - 6467 - MH - CTIL
• Status: Not yet recruiting
• Start date: May 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2020
• Source: Sheba Medical Center
• Contact: Chen Speter
• Phone: +972 052 6668225
• Email: chen.speter[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Atherosclerosis
• Crystallization of Cholesterol in Atherosclerosis

Intervention

Procedure:
• carotid endarterectomy
carotid endarterctomy that is being used for carotid stenosis disease

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Weizmann Institute of Science

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	crystallization of cholesterol in atherosclerosis	Understand the interrelation between structural, morphological and spatial characteristics of cholesterol crystals found within the atherosclerotic lesion and its maturation and destabilization.	3 years