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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01895725
• Other study ID #: P-selectin 03-13
• Status: Active, not recruiting
• Start date: June 2013
• Est. completion date: January 2028

Study information

• Verified date: May 2021
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 443
• Est. completion date: January 2028
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factors
• Cerebrovascular Disease
• Cerebrovascular Disorders
• Coronary Artery Disease
• Peripheral Arterial Disease
• Peripheral Artery Disease

Locations

Country	Name	City	State
Austria	Medical University Innsbruck, Department for Internal Medicine III	Innsbruck

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between P-selectin and the progression of atherosclerosis	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	up to 4 years
Secondary	Correlation of cardiovascular events with the progression of atherosclerosis	As secondary endpoints, cardiovascular events (cardiovascular death, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA), coronary bypass surgery, stroke, transient ischemic attack (TIA), surgery for aortic aneurysm, critical limb ischemia, peripheral percutaneous transluminal angioplasty (PTA), peripheral bypass) will be correlated with the progression of atherosclerosis and the additional predictive value of plaque volume and IMT in carotid and or femoral arteries compared to an established clinical risk score risk score (SCORE card) will be calculated	up to 4 years