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

This study is currently recruiting participants.

Verified by Sheba Medical Center, March 2008

Sponsors and Collaborators:	Sheba Medical Center University Hospital Goettingen Carmel Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00449306

Purpose

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.

Condition
Atherosclerosis Aortic Aneurysm Peripheral Vascular Diseases

MedlinePlus related topics: Aneurysms Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Lipids

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Physical,Histological,and Genetic Analyses of Lipid-Rich Atherosclerotic Plaques

Further study details as provided by Sheba Medical Center:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Tissue for RNA extraction (frozen); Tissue for histological analysis (formalin fixation); Plasma for CV biomarkers (frozen)

Estimated Enrollment:	120
Study Start Date:	March 2001
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Primary Care Clinic patients

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449306

Contacts

Contact: Jacob Schneiderman, MD

972 3 5302712

jschneid@netvision.net.il

Locations

Israel
Sheba Medical Center, Tel Hashomer	Recruiting
Ramat Gan, Israel, 52621
Contact: Jacob Schneiderman, MD 972 3 5302712 jschneid@netvision.net.il

Sponsors and Collaborators

Sheba Medical Center

University Hospital Goettingen

Carmel Medical Center

Investigators

Principal Investigator:

Jacob Schneiderman, MD

Department of Vascular Surgery, Sheba Medical Center, Tel Hashomer

More Information

Responsible Party:	Sheba Medical Cener ( Dr. Jacob Schneiderman )
Study ID Numbers:	SHEBA-01-2354-JS-CTIL
Study First Received:	March 19, 2007
Last Updated:	March 16, 2008
ClinicalTrials.gov Identifier:	NCT00449306
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

Atherosclerosis
Carotid plaque
Abdominal aortic aneurysm
Vulnerable plaque

Angiogenesis
Intraplaque hemorrhage
Carotid artery atherosclerosis

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Aortic Diseases
Peripheral Vascular Diseases
Aneurysm
Aortic Aneurysm, Abdominal

Abdominal aortic aneurysm
Vascular Diseases
Arteriosclerosis
Hemorrhage
Aortic Aneurysm

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009