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ACTIVE NOT RECRUITING
NCT01895725

Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin

Sponsor: Medical University Innsbruck

View on ClinicalTrials.gov

Summary

The proposed project is a prospective observational, single-center cohort study aimed to examine the progression of atherosclerotic alterations of the carotid arteries (IMT, plaque volume) during a follow-up of up to four years and to correlate the observed changes with traditional and novel biomarkers of atherosclerosis. A total of 600 subsequent patients with or established cardiovascular disease or at least one cardiovascular risk will be tested with a high-frequency ultrasound probe equipped with automated IMT measurements and 3D quantitative plaque volumetry. Plasma samples will be collected and tested for traditional and novel cardiovascular risk factors. Both ultrasound examinations and blood sampling will be repeated once per year to assess changes in these parameters over time depending on treatment modalities, which are left to the discretion of the treating physicians. The primary endpoint of the planned study will be the correlation between P-selectin and the progression of atherosclerosis as measured by plaque volume and IMT in the carotid and femoral arteries, respectively. Secondary endpoints will include the correlation of established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hsCRP, P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1 (ICAM-1), CETP TaqIb polymorphism) with the progression of atherosclerosis, the correlation of cardiovascular events with the progression of atherosclerosis and the additional predictive value of plaque volume and IMT compared to an established risk score (SCORE card).

Key Details

Gender

All

Age Range

30 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

443

Start Date

2013-06

Completion Date

2028-01

Last Updated

2021-05-14

Healthy Volunteers

No

Locations (1)

Medical University Innsbruck, Department for Internal Medicine III

Innsbruck, Austria