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Clinical Trials/NCT01895725
NCT01895725
Active, not recruiting
Not Applicable

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

Medical University Innsbruck1 site in 1 country443 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Risk Factors
Sponsor
Medical University Innsbruck
Enrollment
443
Locations
1
Primary Endpoint
Correlation between P-selectin and the progression of atherosclerosis
Status
Active, not recruiting
Last Updated
4 years ago

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
January 2028
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical University Innsbruck
Responsible Party
Principal Investigator
Principal Investigator

Peter Marschang

Prof. MD

Medical University Innsbruck

Eligibility Criteria

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

Outcomes

Primary Outcomes

Correlation between P-selectin and the progression of atherosclerosis

Time Frame: 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

Secondary Outcomes

  • Correlation of cardiovascular events with the progression of atherosclerosis(up to 4 years)

Study Sites (1)

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