Crystallization of Cholesterol in AtherosclerosisNCT04257942
Pathological Crystallization of Cholesterol in Atherosclerosis
An observational study of Crystallization of Cholesterol in Atherosclerosis, run by Sheba Medical Center.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crystallization of Cholesterol in Atherosclerosis
- What is being tested?
- carotid endarterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 30 Jun 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with carotid stenosis - symptomatic and asymptomatic
Who may be able to join
- all patients that are being operated on for carotid endarterctomy due to carotid stenosis
Who cannot join
- none
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- carotid endarterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid endarterectomyProcedure or surgery
carotid endarterctomy that is being used for carotid stenosis disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 May 2020 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crystallization of Cholesterol in AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Principal investigator, Dr. Chen Speter, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257942
- Sponsor's protocol ID
- SHEBA - 19 - 6467 - MH - CTIL
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: only the pthological and clinical findings
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathological Crystallization of Cholesterol in Atherosclerosis
- ClinicalTrials.gov ID
- NCT04257942
- Acronym / sponsor ID
- SHEBA - 19 - 6467 - MH - CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Weizmann Institute of Science
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with carotid stenosis - symptomatic and asymptomatic
Key inclusion criteria (1 listed)
- all patients that are being operated on for carotid endarterctomy due to carotid stenosis
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carotid endarterectomycarotid endarterctomy that is being used for carotid stenosis disease | Procedure or surgery | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: Yes. only the pthological and clinical findings
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Crystallization of Cholesterol in Atherosclerosis, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Speter (+972 052 6668225, chen.speter@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
crystallization of cholesterol in atherosclerosis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.