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NCT Number: NCT03164174

Atherosclerosis-Progression in Coronary Arteries Compared to Periphery Vessels

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Innsbruck

Innsbruck, 6020, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation of the atherosclerotic progression between coronary arteries and peripheral arteries

    Time frame: 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 outcomes

  1. Correlation of atherosclerotic progression with established cardiovascular risk factors

    Time frame: 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

  2. Correlation of atherosclerotic progression with novel cardiovascular risk factors

    Time frame: 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.

  3. Correlation of atherosclerotic progression with cardiovascular event rate

    Time frame: 2 years

    Atherosclerotic Progression will be measured as stated above. Cardiovascular event rate include MACCE (Major Adverse Cardiac and Cerebrovascular Events)

  4. Additional predictive value of atherosclerotic progression compared to an established risk score (SCORE Card, FRS).

    Time frame: 2 years

    Atherosclerotic Progression will be measured as stated above. Established risk scores include SCORE and FRS.

  5. Comparison of plaque morphology between coronary arteries and peripheral vessels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Acronym: APRICOTS

Important dates

Study start
2017
Primary completion
2021
Study completion
2028
First posted
May 23, 2017
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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