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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Sheba Medical Center.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Arteriosclerosis
Atherosclerosis
Peripheral Arterial Disease
Peripheral Vascular Diseases
Plaque, Atherosclerotic
Vascular Diseases
Aortic Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 25, 2014