Fetal Cardiac Magnetic Resonance in Detection of CHD

Sponsor
University Hospital, Bonn (Other)
Overall Status
Recruiting
CT.gov ID
NCT05066399
Collaborator
(none)
100
1
27.7
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Fetal Cardiac Magnetic Resonance Imaging Using DUS Gating on 3T: Preliminary Experiences in Detection of CHD
    Actual Study Start Date :
    May 11, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • fetuses in third trimenon

    • congenital heart defect suspected by obstetric ultrasound

    Exclusion Criteria:
    • pregnant women with contraindication for native MRI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology Bonn NRW Germany 53127

    Sponsors and Collaborators

    • University Hospital, Bonn

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Julian Alexander Luetkens, Principial Investigator, Senior Physician, University Hospital, Bonn
    ClinicalTrials.gov Identifier:
    NCT05066399
    Other Study ID Numbers:
    • 523/20
    First Posted:
    Oct 4, 2021
    Last Update Posted:
    Oct 4, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 4, 2021