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

This study is currently recruiting participants.

Verified July 2012 by Sheba Medical Center

Sponsor:

Collaborators:

University Hospital Goettingen

Carmel Medical Center

CVpath Institute, Inc.

Information provided by (Responsible Party):

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT00449306

First received: March 19, 2007

Last updated: July 25, 2012

Last verified: July 2012

History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm Atherosclerosis Genetic Testing Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Biospecimen Retention: Samples Without DNA

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:	July 2014
Estimated Primary Completion Date:	July 2013 (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

CVpath Institute, Inc.

Investigators

Principal Investigator:

Jacob Schneiderman, MD

Department of Vascular Surgery, Sheba Medical Center, Tel Hashomer

More Information

No publications provided by Sheba Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00449306 History of Changes
Other Study ID Numbers:	SHEBA-01-2354-JS-CTIL
Study First Received:	March 19, 2007
Last Updated:	July 25, 2012
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

Additional relevant MeSH terms:

Aneurysm
Aortic Aneurysm
Atherosclerosis
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease

Plaque, Atherosclerotic
Cardiovascular Diseases
Aortic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013

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