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临床试验/NCT05066399
NCT05066399Unknown不适用

Fetal Cardiac Magnetic Resonance Imaging Using DUS Gating on 3T: Preliminary Experiences in Detection of CHD

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月11日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
The number of heart defect characteristics detectable by DUS gated Cine MRI imaging

研究概览

简要总结

The aim of this clinical prospective study is to investigate the value of fetal cardiac magnetic resonance imaging using a new Doppler ultrasound based gating method for the detection of congenital heart desease.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • fetuses in third trimenon
  • congenital heart defect suspected by obstetric ultrasound

排除标准

  • pregnant women with contraindication for native MRI

结局指标

主要结局

The number of heart defect characteristics detectable by DUS gated Cine MRI imaging

时间窗: Up to 3 months after birth, cardiac MRI findings will be compared against fetal ultrasound gainst fetal ultrasounand against findings after birth (reference standard).

DUS gated Cine imaging will be applied to detect characteristics of clinically suspected congenital heart defects.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julian Alexander Luetkens

Principial Investigator, Senior Physician

University Hospital, Bonn

研究点 (1)

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