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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Peripheral Artery Disease; Cardiovascular Risk Factors; Cerebrovascular Disease

• Study Type: Observational
• Enrollment (Actual): 443

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medical University Innsbruck, Department for Internal Medicine III

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Peter Marschang, MD, Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): January 30, 2020
• Study Completion (Anticipated): January 1, 2028

Study Registration Dates

• First Submitted: June 28, 2013
• First Submitted That Met QC Criteria: July 5, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Coronary Disease; Peripheral Vascular Diseases; Coronary Artery Disease; Peripheral Arterial Disease; Cerebrovascular Disorders
• Other Study ID Numbers: P-selectin 03-13