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

This study is ongoing, but not recruiting participants.
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: December 15, 2015
Last verified: December 2015
  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:

Primary Outcome Measures:
  • To uncover mechanisms of cardiovascular diseases [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Locations
Israel
Sheba Medical Center, Tel Hashomer
Ramat Gan, Israel, 52621
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

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: December 15, 2015
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:
Atherosclerosis
Aneurysm
Vascular Diseases
Aortic Aneurysm
Peripheral Vascular Diseases
Peripheral Arterial Disease
Plaque, Atherosclerotic
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Aortic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 23, 2016