Atherosclerosis-Progression in Coronary Arteries Compared to Periphery Vessels

Active, not recruiting

• Conditions: Atherosclerosis

• Registration Number: NCT03164174
• Lead Sponsor: Medical University Innsbruck

Brief Summary

The study is a prospective-observational, explorative single-centre cohort study aimed to examine the atherosclerosis progression in coronary arteries compared to peripheral vessels (carotids, femoral arteries). Atherosclerotic alterations in peripheral vessels (IMT, plaque volume, plaque morphology) will be measured with ultrasound (IMT measurements and 3D quantitative plaque volumetry), whereas atherosclerotic alterations in coronary arteries will be tested with cardiac computertomography (CT) (coronary artery calcium score, calcium volume score, plaque morphology).

A total of 55 patients without prior known established vascular diseases will be tested. Cardiac CT and ultrasonography will be performed initially. After 2 years follow-up CT and ultrasound examination will be performed to assess the changes in atherosclerotic burden. Initially and after two years plasma samples will be collected and tested for traditional and novel cardiovascular risk factors.

The primary endpoint of the planned study will be the correlation of the atherosclerotic progression between coronary arteries and peripheral arteries (carotids, femoral arteries).

Secondary endpoints will include the correlation of atherosclerotic progression with 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 cardiovascular event rate, and the additional predictive value of atherosclerotic progression compared to an established risk score (SCORE Card, FRS). Also plaque morphology will be compared between coronary arteries and peripheral vessels.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-16
• Study Start: 2017-05-17
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-23
• Primary Completion: 2021-01-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-05-17
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Age 30-85 years, no prior established vascular diseases (CAD, PAD, cerebrovascular disease) no diabetes

Exclusion Criteria

• Prior myocardial revascularisation therapy (aortocoronary bypass, PCI with stent implantation), coronary artery disease (CAD), peripheral artery disease (PAD), cerebrovascular disease (e.g.stroke), diabetes, pregnancy, lactation period, chronic renal insufficiency IIIB or lower (GFR <45ml/min), manifest hyperthyreosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of the atherosclerotic progression between coronary arteries and peripheral arteries	2 years	Atherosclerotic progression in peripheral vessels (carotids, femoral arteries) will be tested with 3D-ultrasonography and a quantitative 3-D Plaque volumetry will be performed (total plaque volume).Atherosclerotic progression in coronary arteries will be measured with cardiac CT and coronary plaque burden will be assessed (calcium volume score). The percent change of atherosclerotic progression in peripheral vessels (percent change in total plaque volume, mm3) and coronary arteries (percent change in calcium score, Agatston units) will be compared.

Secondary Outcome Measures

Name	Time	Method
Correlation of atherosclerotic progression with cardiovascular event rate	2 years	Atherosclerotic Progression will be measured as stated above. Cardiovascular event rate include MACCE (Major Adverse Cardiac and Cerebrovascular Events)
Comparison of plaque morphology between coronary arteries and peripheral vessels	2 years	Plaque morphology in peripheral arteries will be measured with ultrasound. Therefore Gray-Weale-Score, Grey scale median and plaque structure will be assessed. For cardiac CT the noncalcifying burden atheroma score and high risk plaque criteria will be measured. Plaque morphology in peripheral arteries as measured by ultrasound and in coronary arteries as determined by CT will be compared in a qualitative manner.
Correlation of atherosclerotic progression with established cardiovascular risk factors	2 years	Atherosclerotic Progression will be measured as stated above (total plaque volume for peripheral vessels, calcium volume score for coronary arteries). Cardiovascular risk factors include hypertension, smoking, diabetes, dyslipidemia
Correlation of atherosclerotic progression with novel cardiovascular risk factors	2 years	Atherosclerotic progression will be measured as stated above. Novel cardiovascular risk factors include hsCRP, P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1 (ICAM-1), CETP TaqIb polymorphism, lipocalin,catestatin.
Additional predictive value of atherosclerotic progression compared to an established risk score (SCORE Card, FRS).	2 years	Atherosclerotic Progression will be measured as stated above. Established risk scores include SCORE and FRS.

Trial Locations

Locations (1)

Medical University Innsbruck; 🇦🇹 Innsbruck, Austria