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
- 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: