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

NCT01895725 | Active Not Recruiting

• 1 other identifier: P-selectin 03-13
• Study Type: observational
• Target: 443
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiovascular Risk Factors; Coronary Artery Disease; Cerebrovascular Disease; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation of cardiovascular events with the progression of atherosclerosis

  up to 4 years

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• lack of informed consent
• the impossibility of follow-up testing once per year for the following four years

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck, Department for Internal Medicine III

Innsbruck, 6020, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples

MeSH Terms

Conditions

Coronary Artery Disease; Cerebrovascular Disorders; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Atherosclerosis; Peripheral Vascular Diseases

Study Officials

• Peter Marschang, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 10, 2013
• Study Start: June 1, 2013
• Primary Completion: January 30, 2020
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

AU (1)