跳至主要内容
临床试验/NCT06149195
NCT06149195Enrolling By Invitation不适用

18F-meta-fluorobenzylguanidine Cardiac Imaging for Evaluation of Chronic Heart Failure

Sichuan Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1
主要终点
observe the 18F-MFBG distribution of the myocardium in heart failure patients

研究概览

简要总结

The clinical feasibility of 18F-FMBG cardiac PET imaging will be observed in sympathetic nervous system activity in patients with heart failure, predicted cardiac events, guided ICD implantation, and evaluated therapy efficiency.

详细描述

This is a prospective, single-center clinical study, using18F-meta-fluorobenzylguanidine (18F-MFBG) cardiac PET imaging to present the sympathetic nerve status in heart failure, including ICD implantation. Through follow-up, we analyze the correlation between the distribution of the tracer in the heart and the functions and progression of the patients, including the occurrence of ventricular arrhythmias and sudden cardiac death, And further investigate the guiding value of 18F-MFBG cardiac sympathetic nerve imaging in the screening of ICD implantation patients, including primary and secondary prevention, reducing the cost of ICD implantation and related complications. Furthermore, to evaluate the therapy efficacy for these patients with heart failure using 18F-MFBG cardiac imaging has been considered.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically confirmed patient with chronic heart failure, LVEF ≤ 40%, cardiac function NYHA 2-3 grade, survival period greater than 1 year, evaluated by the Heart Failure Center of Sichuan Provincial People's Hospital.
  • Chronic heart failure patients were evaluated by the Cardiology Department of Sichuan Provincial People's Hospital 5-10 days before ICD implantation.
  • All patients above have signed an informed consent form.

排除标准

  • Heart failure, heart function NYHA levels ⅠOR Ⅳ.
  • The patient has already implanted ICD or CRT.
  • Heart transplant patients.
  • Patients with malignant tumors.
  • Heart valve disease.
  • Myocardial infarction occurred within the past three months.
  • The patient has contraindications for ICD implantation surgery.
  • The patient does not cooperate or is unwilling to conduct the study.

结局指标

主要结局

observe the 18F-MFBG distribution of the myocardium in heart failure patients

时间窗: 1 year

18F-MFBG PET cardiac sympathetic nerve imaging was performed after injection of 30 minutes and 3 hours. The imaging agent distribution of left ventricular walls was observed at three axis positions (short axis, horizontal long axis, and vertical long axis). Target heart maps (17 segments) were obtained using Cedars QPS software to obtain radiation distribution counts (SMSe, SMSlate).

次要结局

未报告次要终点

研究者

发起方
Sichuan Provincial People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hao Wang

Associate senior physician

Sichuan Provincial People's Hospital

研究点 (1)

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