NCT01895725Active, not recruiting
Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin
Source: ClinicalTrials.gov · Last updated 14 May 2021
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 443 (actual)
- First submitted
- 28 Jun 2013
- Start date
- Jun 2013
- Primary completion date
- 30 Jan 2020
- Lead sponsor
- Medical University Innsbruck
- Diseases
- Coronary artery disease
- NCT number
- NCT01895725
What you commit to
- Study type: Observational
- Participants enrolled: 443
- From Jun 2013 to the primary completion date, 30 Jan 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- lack of informed consent
- the impossibility of follow-up testing once per year for the following four years
Who the study is looking for
- 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
Age in the registry: 30 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University Innsbruck, Department for Internal Medicine III Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.