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NCT00449306 Clinical Trial

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

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00449306
Other study ID # SHEBA-01-2354-JS-CTIL
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 2001
Est. completion date July 2021

Study information
Verified date July 2019
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 120
Est. completion date July 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba Medical Center, Tel Hashomer Ramat Gan

Sponsors (4)
Lead Sponsor Collaborator
Sheba Medical Center Carmel Medical Center, CVpath Institute, Inc., University Hospital Goettingen

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary To uncover mechanisms of cardiovascular diseases 3 years
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