Congenital Heart DiseaseNCT05066399
Fetal Cardiac Magnetic Resonance in Detection of CHD
An observational study of Congenital Heart Disease and Fetal Cardiac Disorder, run by University Hospital, Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease, Fetal Cardiac Disorder, Heart Defect, Congenital
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 11 May 2021to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary care clinic (Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Germany), Prof. Dr. med. Annegret Geipel
Who may be able to join
- fetuses in third trimenon
- congenital heart defect suspected by obstetric ultrasound
Who cannot join
- pregnant women with contraindication for native MRI
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
Bonn, North Rhine-Westphalia, 53127
Julian A Luetkens, PD Dr., julian.luetkens@ukbonn.de
Thomas M Vollbrecht, Dr., thomas.vollbrecht@ukbonn.de
About this study
Official title: Fetal Cardiac Magnetic Resonance Imaging Using DUS Gating on 3T: Preliminary Experiences in Detection of CHD
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.
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months after birth, cardiac MRI findings will be compared against fetal ultrasound gainst fetal ultrasounand against findings after birth (reference standard).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start11 May 2021
- Primary completionJan 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Alexander Luetkens, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066399
- Sponsor's protocol ID
- 523/20
- Status last verified
- Oct 2021
- First submitted
- 22 Sep 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Cardiac Magnetic Resonance Imaging Using DUS Gating on 3T: Preliminary Experiences in Detection of CHD
- ClinicalTrials.gov ID
- NCT05066399
- Acronym / sponsor ID
- 523/20
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic (Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Germany), Prof. Dr. med. Annegret Geipel
Key inclusion criteria (2 listed)
- fetuses in third trimenon
- congenital heart defect suspected by obstetric ultrasound
Key exclusion criteria (1 listed)
- pregnant women with contraindication for native MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of heart defect characteristics detectable by DUS gated Cine MRI imaging
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Fetal Cardiac Disorder, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian A. Luetkens, PD Dr. (+49 228 287-15960, julian.luetkens@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of heart defect characteristics detectable by DUS gated Cine MRI imaging (time frame: Up to 3 months after birth, cardiac MRI findings will be compared against fetal ultrasound gainst fetal ultrasounand against findings after birth (reference standard).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.