- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04257942
Pathological Crystallization of Cholesterol in Atherosclerosis
February 4, 2020 updated by: Dr. Chen Speter, Sheba Medical Center
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.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chen Speter
- Phone Number: +972 052 6668225
- Email: chen.speter@sheba.health.gov.il
Study Contact Backup
- Name: Moshe Halak
- Phone Number: +972 052 6666210
- Email: moshe.halak@sheba.health.gov.il
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with carotid stenosis - symptomatic and asymptomatic
Description
Inclusion Criteria:
- all patients that are being operated on for carotid endarterctomy due to carotid stenosis
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
crystallization of cholesterol in atherosclerosis
Time Frame: 3 years
|
Understand the interrelation between structural, morphological and spatial characteristics of cholesterol crystals found within the atherosclerotic lesion and its maturation and destabilization.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2020
Primary Completion (Anticipated)
May 1, 2020
Study Completion (Anticipated)
June 30, 2021
Study Registration Dates
First Submitted
February 4, 2020
First Submitted That Met QC Criteria
February 4, 2020
First Posted (Actual)
February 6, 2020
Study Record Updates
Last Update Posted (Actual)
February 6, 2020
Last Update Submitted That Met QC Criteria
February 4, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA - 19 - 6467 - MH - CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
only the pthological and clinical findings
IPD Sharing Time Frame
2023- forever
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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