Atherosclerosis-Progression in Coronary Arteries Compared to Periphery Vessels

NCT03164174 | Active Not Recruiting

• 1 other identifier: AN2016-0188 366/4.3
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Correlation of the atherosclerotic progression between coronary arteries and peripheral arteries

  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.

  2 years

Secondary Outcomes (5)

• Correlation of atherosclerotic progression with established cardiovascular risk factors

  2 years

• Correlation of atherosclerotic progression with novel cardiovascular risk factors

  2 years

• Correlation of atherosclerotic progression with cardiovascular event rate

  2 years

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

  2 years

• Comparison of plaque morphology between coronary arteries and peripheral vessels

  2 years

Eligibility Criteria

• Age: 30 Years - 85 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 23, 2017
• Study Start: May 17, 2017
• Primary Completion: January 12, 2021
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

AU (1)