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