跳至主要内容
临床试验/NCT01895725
NCT01895725进行中(未招募)不适用

Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin

Medical University Innsbruck1 个研究点 分布在 1 个国家目标入组 443 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
443
试验地点
1
主要终点
Correlation between P-selectin and the progression of atherosclerosis

研究概览

简要总结

The proposed project is a prospective observational, single-center cohort study aimed to examine the progression of atherosclerotic alterations of the carotid arteries (IMT, plaque volume) during a follow-up of up to four years and to correlate the observed changes with traditional and novel biomarkers of atherosclerosis. A total of 600 subsequent patients with or established cardiovascular disease or at least one cardiovascular risk will be tested with a high-frequency ultrasound probe equipped with automated IMT measurements and 3D quantitative plaque volumetry. Plasma samples will be collected and tested for traditional and novel cardiovascular risk factors. Both ultrasound examinations and blood sampling will be repeated once per year to assess changes in these parameters over time depending on treatment modalities, which are left to the discretion of the treating physicians. The primary endpoint of the planned study will be the correlation between P-selectin and the progression of atherosclerosis as measured by plaque volume and IMT in the carotid and femoral arteries, respectively. Secondary endpoints will include the correlation of 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 the progression of atherosclerosis, the correlation of cardiovascular events with the progression of atherosclerosis and the additional predictive value of plaque volume and IMT compared to an established risk score (SCORE card).

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

入选标准

  • Patients (male and female) aged 30 to 85 years
  • with at least one traditional cardiovascular risk factor (hypertension, smoking, diabetes, dyslipidemia, family history) or established coronary artery disease, cerebrovascular disease, or peripheral artery disease diagnosed by objective testing

排除标准

  • lack of informed consent
  • the impossibility of follow-up testing once per year for the following four years

结局指标

主要结局

Correlation between P-selectin and the progression of atherosclerosis

时间窗: up to 4 years

The primary endpoint of the planned study will be the correlation between P-selectin and the progression of atherosclerosis as measured by plaque volume and IMT in the carotid and femoral arteries

次要结局

  • Correlation of cardiovascular events with the progression of atherosclerosis(up to 4 years)

研究者

发起方
Medical University Innsbruck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Marschang

Prof. MD

Medical University Innsbruck

研究点 (1)

Loading locations...

相似试验