NCT05066399

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

October 4, 2021

Status Verified

October 1, 2021

Enrollment Period

1.6 years

First QC Date

September 22, 2021

Last Update Submit

October 1, 2021

Conditions

Congenital Heart DiseaseFetal Cardiac DisorderHeart Defect, Congenital

Outcome Measures

Primary Outcomes (1)

  • 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).

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic (Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Germany), Prof. Dr. med. Annegret Geipel

You may qualify if:

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

You may not qualify if:

  • pregnant women with contraindication for native MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Julian A. Luetkens, PD Dr.

CONTACT

+49 228 287-15960julian.luetkens@ukbonn.de

Thomas M. Vollbrecht, Dr.

CONTACT

+49 228 287-15960thomas.vollbrecht@ukbonn.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principial Investigator, Senior Physician

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 4, 2021

Study Start

May 11, 2021

Primary Completion

January 1, 2023

Study Completion

September 1, 2023

Last Updated

October 4, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)