AtherosclerosisNCT00449306
Physical,Histological,and Genetic Analyses of Lipid-rich Atherosclerotic Plaques
An observational study of Atherosclerosis and Aortic Aneurysm, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Lipid-rich atherosclerotic plaques, or "vulnerable plaques" are prone to rupture, causing local intravascular thrombosis, with subsequent grave clinical consequences. Atherosclerotic plaques normally removed during surgery, and peripheral blood samples will be studied to achieve the following objectives: "1" Define… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Aortic Aneurysm, Peripheral Vascular Diseases
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2001to Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic patients
Who may be able to join
- Evidence of symptomatic carotid stenosis exceeding 60%(TIAs or stroke within the last 6 months), and asymptomatic carotid artery stenosis (presenting with progressive carotid stenosis, exceeding 70%)
- Abdominal aortic aneurysm, and aortic occlusive disease
- Peripheral occlusive or aneurysmal disease
Who cannot join
- Non-compliant patients, incapable of granting approval by informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Lipid-rich atherosclerotic plaques, or "vulnerable plaques" are prone to rupture, causing local intravascular thrombosis, with subsequent grave clinical consequences. Atherosclerotic plaques normally removed during surgery, and peripheral blood samples will be studied to achieve the following objectives:
"1" Define histological features of the vulnerable plaque, analyze its physical characteristics, and investigate selected gene expression.
"2" Study biomarkers of inflammation in conjunction with the presence of vulnerable plaques.
"3" Explore the potential role of infection in atherogenesis.
- Keywords
- Atherosclerosis, Carotid plaque, Abdominal aortic aneurysm, Vulnerable plaque, Angiogenesis, Intraplaque hemorrhage, Carotid artery atherosclerosis
- Medical subject headings
- Atherosclerosis, Aortic Aneurysm, Peripheral Vascular Diseases, Aortic Aneurysm, Abdominal, Carotid Artery Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
To uncover mechanisms of cardiovascular diseases
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 posted20 Mar 2007 (estimated)
- Study startMar 2001
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- University Hospital Goettingen, Carmel Medical Center, CVPath Institute Inc.
- Responsible party
- Sponsor
- Investigators
- Jacob Schneiderman, MD, Principal investigator, Department of Vascular Surgery, Sheba Medical Center, Tel Hashomer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449306
- Sponsor's protocol ID
- SHEBA-01-2354-JS-CTIL
- Status last verified
- Jul 2019
- First submitted
- 19 Mar 2007
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ben-Zvi D, Savion N, Kolodgie F, Simon A, Fisch S, Schafer K, Bachner-Hinenzon N, Cao X, Gertler A, Solomon G, Kachel E, Raanani E, Lavee J, Kotev Emeth S, Virmani R, Schoen FJ, Schneiderman J. Local Application of Leptin Antagonist Attenuates Angiotensin II-Induced Ascending Aortic Aneurysm and Cardiac Remodeling. J Am Heart Assoc. 2016 May 3;5(5):e003474. doi: 10.1161/JAHA.116.003474.
PubMed 27143353Schneiderman J, Schaefer K, Kolodgie FD, Savion N, Kotev-Emeth S, Dardik R, Simon AJ, Halak M, Pariente C, Engelberg I, Konstantinides S, Virmani R. Leptin locally synthesized in carotid atherosclerotic plaques could be associated with lesion instability and cerebral emboli. J Am Heart Assoc. 2012 Oct;1(5):e001727. doi: 10.1161/JAHA.112.001727. Epub 2012 Oct 25.
PubMed 23316287
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical,Histological,and Genetic Analyses of Lipid-rich Atherosclerotic Plaques
- ClinicalTrials.gov ID
- NCT00449306
- Acronym / sponsor ID
- SHEBA-01-2354-JS-CTIL
- Keywords
- Atherosclerosis, Carotid plaque, Abdominal aortic aneurysm, Vulnerable plaque, Angiogenesis, Intraplaque hemorrhage, Carotid artery atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- University Hospital Goettingen, Carmel Medical Center, CVPath Institute Inc.
- Study start
- Mar 2001
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 20 Mar 2007 (estimated)
- 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.
Lipid-rich atherosclerotic plaques, or "vulnerable plaques" are prone to rupture, causing local intravascular thrombosis, with subsequent grave clinical consequences. Atherosclerotic plaques normally removed during surgery, and peripheral blood samples will be studied to achieve the following objectives:
"1" Define histological features of the vulnerable plaque, analyze its physical characteristics, and investigate selected gene expression.
"2" Study biomarkers of inflammation in conjunction with the presence of vulnerable plaques.
"3" Explore the potential role of infection in atherogenesis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic patients
Key inclusion criteria (3 listed)
- Evidence of symptomatic carotid stenosis exceeding 60%(TIAs or stroke within the last 6 months), and asymptomatic carotid artery stenosis (presenting with progressive carotid stenosis, exceeding 70%)
- Abdominal aortic aneurysm, and aortic occlusive disease
- Peripheral occlusive or aneurysmal disease
Key exclusion criteria (1 listed)
- Non-compliant patients, incapable of granting approval by informed consent
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
To uncover mechanisms of cardiovascular diseases
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 27143353Ben-Zvi D, Savion N, Kolodgie F, Simon A, Fisch S, Schafer K, Bachner-Hinenzon N, Cao X, Gertler A, Solomon G, Kachel E, Raanani E, Lavee J, Kotev Emeth S, Virmani R, Schoen FJ, Schneiderman J. Local Application of Leptin Antagonist Attenuates Angiotensin II-Induced Ascending Aortic Aneurysm and Cardiac Remodeling. J Am Heart Assoc. 2016 May 3;5(5):e003474. doi: 10.1161/JAHA.116.003474.
- Derived from this study: PubMed 23316287Schneiderman J, Schaefer K, Kolodgie FD, Savion N, Kotev-Emeth S, Dardik R, Simon AJ, Halak M, Pariente C, Engelberg I, Konstantinides S, Virmani R. Leptin locally synthesized in carotid atherosclerotic plaques could be associated with lesion instability and cerebral emboli. J Am Heart Assoc. 2012 Oct;1(5):e001727. doi: 10.1161/JAHA.112.001727. Epub 2012 Oct 25.
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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.
Jacob Schneiderman, MD principal investigator
Department of Vascular Surgery, Sheba Medical Center, Tel Hashomer
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 and Aortic Aneurysm, 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 5 Jul 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To uncover mechanisms of cardiovascular diseases (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00449306, which also lists 2 linked publications.
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 5 Jul 2019.