Atherosclerosis-Progression in Coronary Arteries Compared to Periphery Vessels
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Correlation of the atherosclerotic progression between coronary arteries and peripheral arteries
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-85 years, no prior established vascular diseases (CAD, PAD, cerebrovascular disease) no diabetes
排除标准
- •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
结局指标
主要结局
Correlation of the atherosclerotic progression between coronary arteries and peripheral arteries
时间窗: 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.
次要结局
- Correlation of atherosclerotic progression with cardiovascular event rate(2 years)
- Comparison of plaque morphology between coronary arteries and peripheral vessels(2 years)
- Correlation of atherosclerotic progression with established cardiovascular risk factors(2 years)
- Correlation of atherosclerotic progression with novel cardiovascular risk factors(2 years)
- Additional predictive value of atherosclerotic progression compared to an established risk score (SCORE Card, FRS).(2 years)
研究者
Peter Marschang
Ao.Univ.Prof.Dr.
Medical University Innsbruck