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临床试验/NCT03541291
NCT03541291已完成不适用

Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
2
主要终点
Comparison between fetal MRI and fetal echocardiography

研究概览

简要总结

We will test an ultrasound device that uses sound waves to detect the fetal heart beat, and use this device to tell the MRI scanner when to collect pictures of the fetal heart. This will help freeze motion of the fetal heart, to make MRI pictures sharper. This will be important for assessing human fetal heart disease, an active area of research at our institution.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

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

入选标准

  • pregnant adults (age 18 and up) with fetus affected by congenital heart disease
  • singleton pregnancy in their 2nd and 3rd trimesters
  • scheduled for a clinical fetal ultrasound examination at the Fetal Echocardiography Clinic at SickKids

排除标准

  • claustrophobia
  • cardiac pacemaker
  • non-MRI compatible implants
  • non-singleton pregnancy
  • obesity (BMI > 30)

结局指标

主要结局

Comparison between fetal MRI and fetal echocardiography

时间窗: within 2 weeks of participation in the study

Anatomic MR images of the fetal heart will be acquired using prospective gating information from the Doppler ultrasound probe (SMART-SYNC LM03) and used to calculate ejection fraction. These values will be compared with corresponding reference values obtained during the patient's visit to the Fetal Echocardiography Clinic.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mike Seed

Qualified Investigator

The Hospital for Sick Children

研究点 (2)

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