The Application of Total-body 13N-NH3 PET/CT to Study the Blood Perfusion System in Severe AS Patients Before and After TAVR Surgery in the Whole Body
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Evaluation of Multi-Organ Blood Perfusion by Total Body Dynamic uEXPLORER PET/CT Scan
研究概览
简要总结
The aim of our study is to analyze and quantitate whole-body blood perfusion by total-body 13N-NH3 PET/CT(uEXPLORER), and evaluate the influence to other organs in severe AS patients and the impact of TAVR surgery.
详细描述
Participants are invited to participate in a research that seeks to understand the dynamic blood perfusion in severe AS patients in human body. The investigators expect to have twenty-five participants in this study at Renji Hospital, Shanghai. Nine participants will be healthy individuals with no known vascular disease. All the participants will undergo the same procedure. If participants agree to participate in this study, researchers will first interview participants and review the past medical record in order to document the medical history. When the screening procedures confirm that participants are eligible to participate in the study, participants will receive one dose of the non-therapeutic administration of a radioactive tracer called N-13 ammonia(13NH3) , then undergo one total body 13NH3 PET/CT Scan (uEXPLORER) to determine the blood flow value of the brain, kidney and other organs. The total body 13NH3 PET/CT Scan will allow investigators to observe and analyze the real-time blood flow differences between patients with between healthy controls and decreased cardiac function.
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
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Nine healthy volunteers with normal EF values
- •Patients with decreased cardiac function, while their heart function grading above II(New York Heart Association,NYHA)
- •Aged 60~90 years old
- •Written informed consents will be offered and signed by all participants
排除标准
- •History of vascular-related diseases in other organs
- •Severe liver and kidney dysfunctions
- •Patients who are pregnant or breast feeding
- •People under the age of 60 years old
- •Heart function grading below II(NYHA)
- •inability to lie or to maintain posture in the scanner for one hour
研究组 & 干预措施
Healthy controls
All healthy subjects will undergo the following intervention: 13N-NH3 PET/CT scan on the total-body uEXPLORER scanner.
干预措施: total-body PET/CT(uEXPLORER , United Imaging Healthcare, China) (Device)
Patients with cardiac disfunction
All patients will undergo the following intervention: 13N-NH3 PET/CT scan on the total-body uEXPLORER scanner.
干预措施: total-body PET/CT(uEXPLORER , United Imaging Healthcare, China) (Device)
结局指标
主要结局
Evaluation of Multi-Organ Blood Perfusion by Total Body Dynamic uEXPLORER PET/CT Scan
时间窗: 4 years
The total-body 13N-NH3 PET/CT will be adopted to evaluate the blood flow differences in whole body between healthy controls and patients with decreased cardiac function.
次要结局
未报告次要终点
研究者
Yumei Chen
deputy head of the department of nuclear medicine
RenJi Hospital