Fetal Cardiac Magnetic Resonance in Detection of CHD

• Conditions: Fetal Cardiac Disorder; Congenital Heart Disease; Heart Defect, Congenital

• Registration Number: NCT05066399
• Lead Sponsor: University Hospital, Bonn

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-11
• Study First Submitted: 2021-09-22
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-01
• Last Update Submitted: 2021-10-01
• Study First Posted: 2021-10-04
• Last Update Posted: 2021-10-04
• Primary Completion: 2023-01
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• pregnant women with contraindication for native MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of heart defect characteristics detectable by DUS gated Cine MRI imaging	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.

Trial Locations

Locations (1)

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology; 🇩🇪 Bonn, NRW, Germany