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临床试验/NCT05800093
NCT05800093进行中(未招募)不适用

Proteomics and Genomics Combined With CT to Predict CVD

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2023年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
310
试验地点
1
主要终点
Coronary Artery Disease Progression

研究概览

简要总结

This study evaluates plaque progression and characteristics in patients with coronary atherosclerosis.

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
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients between 50 and 75 years old
  • Subjects at intermediate to high risk for ASCVD
  • Asymptomatic patients without cardiac chest pain
  • Evidence of atherosclerosis on baseline CCTA

排除标准

  • Renal insufficiency, defined as eGFR < 30 ml/min
  • History of cardiovascular events (myocardial infarction, peripheral artery disease and ischemic stroke)
  • Use of lipid lowering therapy other than statin, ezetimibe or bempedoic acid monotherapy
  • Change in lipid lowering therapy in the last 6 months
  • Use of more than two antihypertensive agents
  • No coronary atherosclerosis at baseline imaging
  • Active malignancy requiring treatment
  • Atrial fibrillation
  • Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
  • Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

结局指标

主要结局

Coronary Artery Disease Progression

时间窗: Through study completion, between 130-156 weeks

次要结局

  • Presence of obstructive stenosis(Through study completion, between 130-156 weeks)
  • Calcified plaque volume progression(Through study completion, between 130-156 weeks)
  • Change in Pericoronary Adipose Tissue CT-Attenuation(Through study completion, between 130-156 weeks)
  • Non-calcified plaque volume progression(Through study completion, between 130-156 weeks)
  • Progression in number of high-risk plaque characteristics (yes/no)(Through study completion, between 130-156 weeks)
  • Progression in number of significant (>50%) and severe (>70%) stenoses(Through study completion, between 130-156 weeks)
  • Total plaque volume progression(Through study completion, between 130-156 weeks)
  • Low-attenuation plaque volume progression(Through study completion, between 130-156 weeks)
  • CAD-RADS progression (yes/no)(Through study completion, between 130-156 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

E.S.stroes

Principal Investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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