跳至主要内容
临床试验/NCT05868902
NCT05868902招募中不适用

A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients with Suspected Coronary Ischemia.

Genetesis Inc.2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
To collect diagnostic data using SOC diagnostic cardiac PET testing for the purposes of gaining a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia

研究概览

简要总结

A multicenter observational data development registry collecting diagnostic measures via standard of care (SOC) cardiac PET in order gain a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia.

研究设计

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

入排标准

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

入选标准

  • Willing to provide informed consent
  • Male or female, aged 40 and up (inclusive) at the time of enrollment
  • Clinical suspicion of myocardial ischemia that clinician desired cardiac PET
  • Completed cardiac PET within 2 weeks prior to study enrollment

排除标准

  • Patients unable to fit into CardioFlux device.
  • Patients unable to lie supine for 5 minutes.
  • Patients with implanted ferromagnetic objects above the costal margin of the rib cage (implanted pacemakers, cardioverter/defibrillators, infusion pumps, and/or neuro stimulators). NOTE: Sternotomy wires stents are acceptable
  • Ongoing atrial fibrillation or atrial flutter
  • Life expectancy <1 yrs. due to non-cardiovascular comorbidity

结局指标

主要结局

To collect diagnostic data using SOC diagnostic cardiac PET testing for the purposes of gaining a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia

时间窗: 24 months

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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