Atherosclerosis-Progression in Coronary Arteries Compared to Periphery Vessels

NCT ID: NCT03164174

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-17
• Study Completion Date: 2028-01-31

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.

Conditions

Atherosclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Peter Marschang

Ao.Univ.Prof.Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University Innsbruck

Innsbruck, , Austria

Countries

Austria

Other Identifiers

AN2016-0188 366/4.3

Identifier Type: -

Identifier Source: org_study_id