Clinical trial NCT01895725: Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin
Official title: Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Risk Factors
Coronary Artery Disease
Cerebrovascular Disease
Peripheral Artery Disease
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 443
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to ultrasound examinations of the carotid and/or femoral arteries for standard indications will be screened for potential inclusion into the study

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).


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

Primary outcomes:
measure: Correlation between P-selectin and the progression of atherosclerosis
timeFrame: up to 4 years
Secondary outcomes:
measure: Correlation of cardiovascular events with the progression of atherosclerosis
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck, Department for Internal Medicine III
Study officials:
affiliation: Medical University Innsbruck
name: Peter Marschang, MD
role: PRINCIPAL_INVESTIGATOR
References: