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

NCT00449306 | Unknown

• 1 other identifier: SHEBA-01-2354-JS-CTIL
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Aortic Aneurysm; Peripheral Vascular Diseases

Keywords

Atherosclerosis; Carotid plaque; Abdominal aortic aneurysm; Vulnerable plaque; Angiogenesis; Intraplaque hemorrhage; Carotid artery atherosclerosis

Outcome Measures

Primary Outcomes (1)

• To uncover mechanisms of cardiovascular diseases

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary Care Clinic patients

You may qualify if:

• 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

You may not qualify if:

• Non-compliant patients, incapable of granting approval by informed consent

Sponsors & Collaborators

• Sheba Medical Center: lead
• University Hospital Goettingen: collaborator
• Carmel Medical Center: collaborator
• CVPath Institute Inc.: collaborator

Study Sites (1)

Sheba Medical Center, Tel Hashomer

Ramat Gan, 52621, Israel

Location

Related Publications (2)

• Ben-Zvi D, Savion N, Kolodgie F, Simon A, Fisch S, Schafer K, Bachner-Hinenzon N, Cao X, Gertler A, Solomon G, Kachel E, Raanani E, Lavee J, Kotev Emeth S, Virmani R, Schoen FJ, Schneiderman J. Local Application of Leptin Antagonist Attenuates Angiotensin II-Induced Ascending Aortic Aneurysm and Cardiac Remodeling. J Am Heart Assoc. 2016 May 3;5(5):e003474. doi: 10.1161/JAHA.116.003474.

  PMID: 27143353 DERIVED

• 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.

  PMID: 23316287 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Atherosclerosis; Aortic Aneurysm; Peripheral Vascular Diseases; Aortic Aneurysm, Abdominal; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Aneurysm; Aortic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jacob Schneiderman, MD

  Department of Vascular Surgery, Sheba Medical Center, Tel Hashomer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2007
• First Posted: March 20, 2007
• Study Start: March 1, 2001
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

IL (1)