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临床试验/NCT04723953
NCT04723953已完成不适用

Cardiac Fibroblast Activation Detected by 68Ga-FAPI PET/MR is a Prognostic Indicator in Patients With Myocardial Infarction.

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2020年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
1
主要终点
Infarction size (IS)

研究概览

简要总结

Myocardial infarction is the most common cause of high mortality in the modern world. The short-term survival rate of ST-elevated myocardial infarction (STEMI) has been dramatically increased in the past decades thanks to primary coronary intervention and standardization of treatment. However, the long-term prognosis of patients with acute myocardial infarction (AMI) is still poor, especially in the aging population, due to heart failure related to inappropriate myocardial fibrosis and subsequent left ventricular (LV) remodeling. Despite the amelioration of STEMI management, LV remodeling still occurs in approximately 1/3 of all STEMI patients. Therefore, early identification of such patients may help the optimization of therapy and eventually the outcomes.

One characteristic of activated cardiac fibroblasts is the expression of FAP (fibroblast activation protein). A tracer (FAP inhibitor) for positron emission tomography that targets FAP has been used to measure relative FAP density indicative of activated fibroblasts in different cancer entities. However, whether it can reliably assess myocardial fibrosis and predict the poor prognosis caused by LV remodeling is not yet known. Therefore, We aim to observe active myocardial fibrosis process in patients with AMI, and analyze its relationship with the patients'prognosis in a longitudinal study through 68Ga-FAPI PET/MRI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between 18-75 years old
  • diagnosed with coronary angiography
  • performed percutaneous coronary intervention,with successful myocardial reperfusion

排除标准

  • unstable hemodynamics
  • MR contraindications (such as pacemaker or nerve stimulator or metal foreign body, high fever, severe renal failure, etc.)
  • Claustrophobia

结局指标

主要结局

Infarction size (IS)

时间窗: Six months after acute myocardial infarction

Percentage of late gadolinum enhancement area in the entire myocardium on MRI

Target-to-background Ratio (TBR)

时间窗: Six months after acute myocardial infarction

68Ga-FAPI uptake ratio of highly active fibrotic myocardium to heart blood pool on PET images

Ejection fraction (EF)

时间窗: Six months after acute myocardial infarction

Left ventricular ejection function evaluated on MRI

Metabolic volume (MV)

时间窗: Six months after acute myocardial infarction

Volume of highly active fibrotic myocardium on PET images

次要结局

  • NT-pro-BNP(Six months after acute myocardial infarction)
  • hsCRP(Six months after acute myocardial infarction)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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