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

March 19, 2007
July 25, 2012
March 2001
July 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00449306 on ClinicalTrials.gov Archive Site
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Physical,Histological,and Genetic Analyses of Lipid-rich Atherosclerotic Plaques
Physical,Histological,and Genetic Analyses of Lipid-rich Atherosclerotic Plaques

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Retention:   Samples Without DNA
Description:

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

Probability Sample

Primary Care Clinic patients

  • Atherosclerosis
  • Aortic Aneurysm
  • Peripheral Vascular Diseases
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
July 2014
July 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Jacob Schneiderman, MD 972 3 5302712 jschneid@netvision.net.il
Israel
 
NCT00449306
SHEBA-01-2354-JS-CTIL
No
Sheba Medical Center
Sheba Medical Center
  • University Hospital Goettingen
  • Carmel Medical Center
  • CVpath Institute, Inc.
Principal Investigator: Jacob Schneiderman, MD Department of Vascular Surgery, Sheba Medical Center, Tel Hashomer
Sheba Medical Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP