AtherosclerosisNCT04487223
Characterization of Novel Lipoprotein Properties Associated With an Increased Risk to Develop Atherosclerosis
An observational study of Atherosclerosis, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Apr 2020to 27 Apr 2022
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Lipid center
Tel HaShomer, 5265601
tamar luvish, BSN, 972-35303492, tamar.luvish@sheba.health.gov.il
About this study
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.
Read the 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
- Conditions
- Atherosclerosis
- Medical subject headings
- Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of novel lipoprotein properties associated with an increased risk to develop atherosclerosis
Lipoproteins would be analyzed by lipidomic and proteomic profiling using chromatography and mass-spectrometry. Concentrations of specific lipids and proteins will be quantified as micrograms per deciliter or as area under the curve. We will look for significant differences in these values between the different study groups using updated software tools specifically designed for mass spectrometry data analysis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start27 Apr 2020
- Primary completion27 Apr 2022 (estimated)
- Study completion27 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Rom Keshet, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487223
- Sponsor's protocol ID
- 6500-19-SMC
- Status last verified
- Sep 2021
- First submitted
- 7 Jul 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Novel Lipoprotein Properties Associated With an Increased Risk to Develop Atherosclerosis
- ClinicalTrials.gov ID
- NCT04487223
- Acronym / sponsor ID
- 6500-19-SMC
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 27 Apr 2022 (estimated)
- Study completion
- 27 Apr 2022 (estimated)
- First posted
- 27 Jul 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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of novel lipoprotein properties associated with an increased risk to develop atherosclerosis
Time frame: 1 year
Lipoproteins would be analyzed by lipidomic and proteomic profiling using chromatography and mass-spectrometry. Concentrations of specific lipids and proteins will be quantified as micrograms per deciliter or as area under the curve. We will look for significant differences in these values between the different study groups using updated software tools specifically designed for mass spectrometry data analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Sheba Medical Center at 1 site in Israel.
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 3 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 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Tamar Luvish, BSN (972-35303492, tamar.luvish@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of novel lipoprotein properties associated with an increased risk to develop atherosclerosis (time frame: 1 year). 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 4 Oct 2021.