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

NCT01895725 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 443

Last updated 2021-05-14

No results posted yet for this 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).

Conditions

Sponsors & Collaborators

  • Medical University Innsbruck

    lead OTHER

Principal Investigators

  • Peter Marschang, MD · Medical University Innsbruck

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2020-01-30
Completion
2028-01-31

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01895725 on ClinicalTrials.gov