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Clinical Trials in Austria / NCT01895725
Active, not recruiting Observational

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

NCT01895725 · tracked via the Priya Life Science Austria tracker
Sponsor
Medical University Innsbruck
Phase
Observational
Started
2013-06
Last updated
2021-05-14

Condition(s) studied

Cardiovascular Risk FactorsCoronary Artery DiseaseCerebrovascular DiseasePeripheral Artery Disease

Study 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).

Eligibility

Sex
ALL
Min age
30 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Correlation between P-selectin and the progression of atherosclerosis — up to 4 years
    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

Trial sites (1)

FacilityCityRegionStatus
Medical University Innsbruck, Department for Internal Medicine III Innsbruck Austria

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01895725 on ClinicalTrials.gov ↗ ← All trials in Austria