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NCT05066399 Clinical Trial

Fetal Cardiac Magnetic Resonance in Detection of CHD

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05066399
Other study ID # 523/20
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 11, 2021
Est. completion date September 2023

Study information
Verified date October 2021
Source University Hospital, Bonn
Contact Julian A. Luetkens, PD Dr.
Phone +49 228 287-15960
Email julian.luetkens@ukbonn.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date September 2023
Est. primary completion date January 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - fetuses in third trimenon - congenital heart defect suspected by obstetric ultrasound Exclusion Criteria: - pregnant women with contraindication for native MRI

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology Bonn NRW

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of heart defect characteristics detectable by DUS gated Cine MRI imaging DUS gated Cine imaging will be applied to detect characteristics of clinically suspected congenital heart defects. Up to 3 months after birth, cardiac MRI findings will be compared against fetal ultrasound gainst fetal ultrasounand against findings after birth (reference standard).
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