Physical,Histological,and Genetic Analyses of Lipid-rich Atherosclerotic Plaques

NCT ID: NCT00449306

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-03-31

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atherosclerosis Aortic Aneurysm Peripheral Vascular Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Non-compliant patients, incapable of granting approval by informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Goettingen

OTHER

Sponsor Role collaborator

Carmel Medical Center

OTHER

Sponsor Role collaborator

CVPath Institute Inc.

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Schneiderman, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Vascular Surgery, Sheba Medical Center, Tel Hashomer

Locations

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Sheba Medical Center, Tel Hashomer

Ramat Gan, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 27143353 (View on PubMed)

Schneiderman 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.

Reference Type DERIVED
PMID: 23316287 (View on PubMed)

Other Identifiers

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SHEBA-01-2354-JS-CTIL

Identifier Type: -

Identifier Source: org_study_id

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