Clinical trial NCT03164174: Atherosclerosis-Progression in Coronary Arteries Compared to Periphery Vessels
Official title: Atherosclerosis-Progression in Coronary Arteries Compared to Periphery Vessels
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atherosclerosis
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-diabetic patients without prior established vascular diseases (CAD, PAD, cerebrovascular disease) will be included in the study.

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.


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

Primary outcomes:
measure: Correlation of the atherosclerotic progression between coronary arteries and peripheral arteries
timeFrame: 2 years
Secondary outcomes:
measure: Correlation of atherosclerotic progression with established cardiovascular risk factors
timeFrame: 2 years
measure: Correlation of atherosclerotic progression with novel cardiovascular risk factors
timeFrame: 2 years
measure: Correlation of atherosclerotic progression with cardiovascular event rate
timeFrame: 2 years
measure: Additional predictive value of atherosclerotic progression compared to an established risk score (SCORE Card, FRS).
timeFrame: 2 years
measure: Comparison of plaque morphology between coronary arteries and peripheral vessels
timeFrame: 2 years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
Study officials:
References: