Congenital Heart Disease Clinical Trial
Official title:
Fetal Cardiac Magnetic Resonance Imaging Using DUS Gating on 3T: Preliminary Experiences in Detection of CHD
| 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 |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology | Bonn | NRW |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Bonn |
Germany,
| 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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