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临床试验/NCT03637725
NCT03637725已完成不适用

Multi-center Trial of SPECT Myocardial Blood Flow Quantitation for Detection of Coronary Artery Disease

China National Center for Cardiovascular Diseases4 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2018年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
221
试验地点
4
主要终点
The diagnostic accuracy of MBF and MPI

研究概览

简要总结

Patients with suspected or known coronary artery disease who are scheduled for clinically indicated SPECT myocardial perfusion imaging (MPI) and will receive invasive coronary angiogram are recruited to receive SPECT MBF study.

详细描述

Patients with suspected or known coronary artery disease who are scheduled for clinically indicated SPECT myocardial perfusion imaging (MPI) and likely will further receive invasive coronary angiogram will be recruited for a SPECT MBF study. The MBF study will be performed as an adjunct to MPI utilizing the same rest and stress injections of 99mTc-Sestamibi (MIBI) tracer, and the same infusion of dipyridamole, adenosine or adenosine triphosphate for stressing. The MBF study will be completed in single or two days depending on the imaging protocol of MPI for a site. This is an observational study with no interventions to the clinical routine whatsoever. Three models of SPECT (GE NM530c) and SPECT/CT (Siemens Symbia-T16 and -T2) cameras are included to acquire rest/stress dynamic SPECT and MPI data. A CT scan will be acquired for the purpose of attenuation correction. All dynamic images will be reconstructed with physical corrections, including attenuation, scatter, resolution recovery and noise reduction, and processed to quantify MBF with the same kinetic modeling. The imaging processing of MBF study will be conducted with a SPECT MBF dedicated software (MyoFlowQ) in a central lab. MPI images will be collected and independently read by three consensus readers. The angiographic result will be independently reviewed by an interventional cardiologist. Diagnostic performance of SPECT MBF and perfusion will be compared utilizing angiographic result as the reference standard.

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

入选标准

  • Age 18 ~ 79 years old
  • Any CAD risk factor
  • CAD related symptoms
  • Intermediate to high probability of CAD
  • Suspected or known CAD on a stable medication regime
  • Able and willing to comply with the study procedures
  • Written informed consent

排除标准

  • History or risk of severe bradycardia
  • History of myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, valve issue or congenital heart disease
  • Wheezing asthma or COPD
  • Known second- or third-degree AV block
  • Known hypersensitivity to dipyridamole or adenosine
  • Breastfeeding or pregnancy
  • Claustrophobia or inability to lie still in a supine position
  • Unwillingness or inability to provide informed consent

结局指标

主要结局

The diagnostic accuracy of MBF and MPI

时间窗: Through the study completion up to 12 months

The diagnostic accuracy of MBF and MPI while angiography is utilized as the reference standard

次要结局

未报告次要终点

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (4)

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