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

Medical University Innsbruck

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Peripheral Artery Disease; Cerebrovascular Disease; Cardiovascular Risk Factors

Study type: Observational

Funder types: Other

Identifiers

NCT01895725

P-selectin 03-13

Details and patient eligibility

About

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).

Enrollment: 443 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients (male and female) aged 30 to 85 years
• with at least one traditional cardiovascular risk factor (hypertension, smoking, diabetes, dyslipidemia, family history) or established coronary artery disease, cerebrovascular disease, or peripheral artery disease diagnosed by objective testing

Exclusion criteria

• lack of informed consent
• the impossibility of follow-up testing once per year for the following four years