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临床试验/NCT06280287
NCT06280287招募中不适用

PET Imaging of Fibroblast Activation in Carotid and Coronary Atherosclerotic Disease

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
SUVmax of atherosclerotic plaque in carotid or coronary arteries

研究概览

简要总结

Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis, associated with endothelial-to-mesenchymal transition and a rupture-prone plaque phenotype. This study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome.

详细描述

Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis. Abundant FAP-expressing cells in atherosclerotic plaques co-express endothelial biomarkers involved in endothelial-to-mesenchymal transition. FAP upregulation is also associated with a rupture-prone plaque phenotype with a thin fibrous cap. Positron emission tomography (PET) with 68Ga-FAPI-04 has been demonstrated as a feasible method to image fibroblastic activation in the arterial wall. The current study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For the carotid stenosis group: patients with symptomatic carotid stenosis with >50% stenosis on carotid CTA; OR patients with unsymptomatic carotid stenosis with >70% stenosis on carotid CTA
  • For CAD group: patients with stable ischemic heart disease OR acute coronary syndrome, including ST-elevation MId, non-ST elevation MI, and unstable angina
  • signed informed consent

排除标准

  • Pregnancy, lactation, or intention to become pregnant during the study
  • Contradiction to MRI or CTA

结局指标

主要结局

SUVmax of atherosclerotic plaque in carotid or coronary arteries

时间窗: through study completion, an average of 2 years

TBR of atherosclerotic plaque in carotid or coronary arteries

时间窗: through study completion, an average of 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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