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临床试验/NCT05269446
NCT05269446已完成不适用

Total-body 18F-PBR06 PET/CT to Evaluate Systemic Inflammation and Perfusion in STEMI and SA Patients Receiving PCI

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Change from baseline TSPO uptake (SUV max) at 6 month

研究概览

简要总结

The study will use 18F-PBR06/uExplorer to study the activation of macrophages and systemic perfusion in patients with ST-segment elevation myocardial infarction (STEMI) or stable angina (SA). Participants will receive the total-body PET/CT scan on the seventh day (Day 7, D7) and D180 of enrolment.

详细描述

The aim of our study is to explore the activation of macrophages in patients with ST-segment elevation myocardial infarction (STEMI) or stable angina (SA) using the 18 kDa translocator protein (TSPO) radioligand 18F N-fluoroacetyl-N-(2,5-dimethoxybenzyl)-2-phenoxyaniline (18F-PBR06) in combination with the world's first commercially available total-body PET/CT (uExplorer). The investigators expect to enroll 10 patients diagnosed with STEMI and 10 patients with SA who receive coronary angiography (CAG) and the percutaneous coronary intervention (PCI), and 5-10 healthy individuals diagnosed with SA but presenting negative CAG at Renji Hospital, Shanghai. The activation of macrophages (TSPO uptake) and blood perfusion in different organs will be studied using 18F-PBR06/uExplorer.

With written consent from eligible participants, the investigators will review past medical records and document the medical history for each participant. Patients will undergo PCI on the day of enrolment (12 hours within the symptom onset for STEMI patients). Screen procedures will be performed at the seventh day of enrolment (Day 7, D7) and Day 180 (D180). Participants will receive one dose of the non-therapeutic administration of the radioactive TSPO tracer 18F-PBR06 and receive a whole-body scan by uExplorer. TSPO uptake and blood flow in the heart, kidney, liver, brain, and lung will be recorded. All participants will be followed for 1 year after enrolment. Blood samples will be collected and echocardiography will be performed at D7 and D180. Major adverse cardiovascular events (MACE) will be recorded throughout the follow-up.

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

入选标准

  • Aged 18-75 years old
  • Diagnosed with STEMI, NSTEMI or suspected SA (ACC/AHA guidelines)
  • Half male and half female
  • Undergo CAG and PCI treatment if necessary (primary PCI for STEMI patients within12 hours after symptom onset)
  • Written informed consents will be offered and signed by all participants

排除标准

  • History of myocardial infarction/vascular disease/heart failure/systemic inflammatory diseases before enrolment
  • Patients who are pregnant/breastfeeding, or in a plan to have a baby during the year after CAG/PCI
  • People under the age of 18 years old
  • Inability to lie or maintain posture during the scanning procedure

研究组 & 干预措施

STEMI patients

STEMI: patients diagnosed with ST-segment elevation myocardial infarction

干预措施: percutaneous coronary intervention (PCI) (Procedure)

STEMI patients

STEMI: patients diagnosed with ST-segment elevation myocardial infarction

干预措施: total body PET/CT scan (Device)

STEMI patients

STEMI: patients diagnosed with ST-segment elevation myocardial infarction

干预措施: Coronary Angiography (CAG) (Procedure)

STEMI patients

STEMI: patients diagnosed with ST-segment elevation myocardial infarction

干预措施: TSPO injection (Drug)

SA or NSTEMI patients

SA: patients diagnosed with stable angina

干预措施: percutaneous coronary intervention (PCI) (Procedure)

SA or NSTEMI patients

SA: patients diagnosed with stable angina

干预措施: total body PET/CT scan (Device)

SA or NSTEMI patients

SA: patients diagnosed with stable angina

干预措施: Coronary Angiography (CAG) (Procedure)

SA or NSTEMI patients

SA: patients diagnosed with stable angina

干预措施: TSPO injection (Drug)

Healthy subjects

Patients with suspected coronary artery disease, but coronary angiography (CAG) indicates no obvious coronary stenosis

干预措施: total body PET/CT scan (Device)

Healthy subjects

Patients with suspected coronary artery disease, but coronary angiography (CAG) indicates no obvious coronary stenosis

干预措施: Coronary Angiography (CAG) (Procedure)

Healthy subjects

Patients with suspected coronary artery disease, but coronary angiography (CAG) indicates no obvious coronary stenosis

干预措施: TSPO injection (Drug)

结局指标

主要结局

Change from baseline TSPO uptake (SUV max) at 6 month

时间窗: Day 7 and Day 180 after enrolment

TSPO uptake is assessed by drawing regions of interest (ROI), and determined as the mean of maximal standard uptake value (SUV max)

Change from baseline Blood flow value (ml/g/min) at 6 month

时间窗: Day 7 and Day 180 after enrolment

Blood flow value is quantified using a reconstructed model, and determined as ml/g/min

次要结局

  • Incidence of MACE (%)in patients with STEMI and SA(Throughout the 1 year follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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