ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00449306
Recruitment Status : Active, not recruiting
First Posted : March 20, 2007
Last Update Posted : October 25, 2016
Sponsor:
Collaborators:
University Hospital Goettingen
Carmel Medical Center
CVpath Institute, Inc.
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:

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 or disease
Atherosclerosis Aortic Aneurysm Peripheral Vascular Diseases

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Physical,Histological,and Genetic Analyses of Lipid-rich Atherosclerotic Plaques
Study Start Date : March 2001
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To uncover mechanisms of cardiovascular diseases [ Time Frame: 3 years ]

Biospecimen Retention:   Samples Without DNA
Tissue for RNA extraction (frozen); Tissue for histological analysis (formalin fixation); Plasma for CV biomarkers (frozen)


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 20, 2007    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

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