NCT01895725

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 443 (actual)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cardiovascular Risk Factors
• Coronary Artery Disease
• Cerebrovascular Disease
• Peripheral Artery Disease

Timeline

• Start date: 2013-06-01
• Primary completion: 2020-01-30
• Completion: 2028-01-01
• First posted: 2013-07-10
• Last updated: 2021-05-14

Locations

1 site across 1 country: Austria