Congenital Heart Disease4DFlowFallotNCT03542968
Imaging by 4 DFlow in Patients With Tetralogy of Fallot
A study testing magnetic resonance imaging in people with Congenital Heart Disease, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
Conventionnal cadiac magnetic resonance (CMR) is the reference to assess changes in right heart flow and pulmonary artery hemodynamics in patients with repaired Tetralogy of Fallot. 4D Flow CMR Imaging is a new imaging modality able to assess all of these parameters faster (8 min vs 30 min) and more comfortably. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2017to 11 Apr 2020
- Phase
- Interventional
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - children from the age of 10 and above without any upper age limit;
- giving their informed consent for the study;
- with a corrected tetralogy of Fallot;
- sent for a follow-up imaging examination with endomyocardial fibrosis screening;
Who cannot join
- - pregnant woman;
- children <10 years old;
- All contraindications inherent to MRI: (claustrophobia, ferromagnetic intracorporeal foreign bodies)
- Contraindication to contrast media injection (Gadolinium)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350
Marc antoine ISORNI, +33140948554, ma-isorni@hml.fr
About this study
Conventionnal cadiac magnetic resonance (CMR) is the reference to assess changes in right heart flow and pulmonary artery hemodynamics in patients with repaired Tetralogy of Fallot.
4D Flow CMR Imaging is a new imaging modality able to assess all of these parameters faster (8 min vs 30 min) and more comfortably.
The aim of this study is to compare conventionnal CMR and 4D Flow CMR for the assessment of these parameters (ventricular volume, ventricular systolic function, and regurgitation of the pulmonary pathway).
Read the detailed description
Congenital heart disease, or corrected heart disease requires regular, specialized follow-up throughout the life of these patients. Among the recommended examinations, cardiac MRI is the reference for functionnal ventricles assessment (volume/systolic function), particularly for the right ventricle.
Among these pathologies, the tetralogy of Fallot is indicative of the increasing importance of cardiac MRI. In this disease, strong parameters has been identifies for the follow to prevent right ventricle dysfunction and ventricular arrhythmias. They rely on right ventricle volumes and on the pulmonary artery regurgitation, both using cardiac MRI.
However, this imaging modality imposes constraints such as a long acquisition times (30 to 40 min) or the need to hold apneas, which may render the procedure uncomfortable, even more in the case of very young patients.
The idea of exploring a new imaging modality is therefore based on the willingness to offer a faster and more comfortable examination. 4D Flow MRI could enable conventionnal parameters, detection of both normal and abnormal right heart flow patterns, and may allow comprehensive analysis of post-surgically altered geometries and hemodynamics.
4D Flow MRI cardiac imaging is :
- A single and faster acquisition (8 to 15 minutes) that cardiac MRI.
- A free breathing acquisition Imaging modality.
- A quite-isotropic assessment.
- A technically simple exam (a single sequence requiring low competence).
- And offers unlimited post processing.
The investigators hypothesize that 4D MRI is non-inferior to 2D MRI in patients with corrected tetralogy of Fallot, for the evaluation of conventional cardiac evaluation parameters: ventricular volume, ventricular systolic function, and regurgitation of the pulmonary pathway.
The investigators hypothesize that 4D MRI is superior to 2D MRI in patients with corrected tetralogy of Fallot, as ti allows to identifying new predictors of ventricular dysfunction such as intravenous extracardiac turbulent / laminar flow character, preferential orientation, flow distribution and trans-tricuspid diastolic flow.
- Conditions
- Congenital Heart Disease
- Being tested
- magnetic resonance imaging
- Keywords
- Congenital heart disease, Tetralogy of Fallot, Imaging by 4D Flow,, Magnetic resonance imaging, Prevention of ventricular dysfunction
- Medical subject headings
- Heart Defects, Congenital, Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingProcedure or surgery
Acquisition 4D Flow magnetic resonance Imaging-8 minutes
| Study group | Role | What they receive |
|---|---|---|
| 4D magnetic resonance imaging | Experimental | MRI, 4D imaging, acquisition and analysis of 4D cardiac MRI images-A single, faster acquisition (8 to 15 minutes). Receives: Procedure: magnetic resonance imaging |
| 2D magnetic resonance imaging | Sham comparator | MRI, 2D imaging, acquisition and analysis of 2D cardiac MRI Receives: Procedure: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI.
Assessment of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI : regurgitation volume (ml) and regurgitation fraction (%).
Measured: 20 min
Secondary outcomes (1)
Compare the evaluation of right ventricle volumes using 2D MRI and 4D Flow MRI.
Assessment of the end-diastolic and end-systolic right ventricle volumes using 2D MRI and 4D Flow MRI (ml).
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start12 Oct 2017
- Primary completion11 Oct 2019
- Study completion11 Apr 2020 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Antoine ISORNI, Doctor, Principal investigator, Hôpital Marie Lannelongue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542968
- Sponsor's protocol ID
- 2017-A01482-51
- Acronym
- 4DFlowFallot
- Status last verified
- Jun 2019
- First submitted
- 4 May 2018
- Last updated
- 23 Jan 2020
- Results posted
- 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 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging by 4 DFlow in Patients With Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT03542968
- Acronym / sponsor ID
- 4DFlowFallot / 2017-A01482-51
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, Tetralogy of Fallot, Imaging by 4D Flow,, Magnetic resonance imaging, Prevention of ventricular dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Apr 2020 (estimated)
- First posted
- 1 Jun 2018 (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.
Conventionnal cadiac magnetic resonance (CMR) is the reference to assess changes in right heart flow and pulmonary artery hemodynamics in patients with repaired Tetralogy of Fallot.
4D Flow CMR Imaging is a new imaging modality able to assess all of these parameters faster (8 min vs 30 min) and more comfortably.
The aim of this study is to compare conventionnal CMR and 4D Flow CMR for the assessment of these parameters (ventricular volume, ventricular systolic function, and regurgitation of the pulmonary pathway).
Detailed description
Congenital heart disease, or corrected heart disease requires regular, specialized follow-up throughout the life of these patients. Among the recommended examinations, cardiac MRI is the reference for functionnal ventricles assessment (volume/systolic function), particularly for the right ventricle.
Among these pathologies, the tetralogy of Fallot is indicative of the increasing importance of cardiac MRI. In this disease, strong parameters has been identifies for the follow to prevent right ventricle dysfunction and ventricular arrhythmias. They rely on right ventricle volumes and on the pulmonary artery regurgitation, both using cardiac MRI.
However, this imaging modality imposes constraints such as a long acquisition times (30 to 40 min) or the need to hold apneas, which may render the procedure uncomfortable, even more in the case of very young patients.
The idea of exploring a new imaging modality is therefore based on the willingness to offer a faster and more comfortable examination. 4D Flow MRI could enable conventionnal parameters, detection of both normal and abnormal right heart flow patterns, and may allow comprehensive analysis of post-surgically altered geometries and hemodynamics.
4D Flow MRI cardiac imaging is :
- A single and faster acquisition (8 to 15 minutes) that cardiac MRI.
- A free breathing acquisition Imaging modality.
- A quite-isotropic assessment.
- A technically simple exam (a single sequence requiring low competence).
- And offers unlimited post processing.
The investigators hypothesize that 4D MRI is non-inferior to 2D MRI in patients with corrected tetralogy of Fallot, for the evaluation of conventional cardiac evaluation parameters: ventricular volume, ventricular systolic function, and regurgitation of the pulmonary pathway.
The investigators hypothesize that 4D MRI is superior to 2D MRI in patients with corrected tetralogy of Fallot, as ti allows to identifying new predictors of ventricular dysfunction such as intravenous extracardiac turbulent / laminar flow character, preferential orientation, flow distribution and trans-tricuspid diastolic flow.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4D magnetic resonance imaging | Experimental | Procedure: magnetic resonance imagingMRI, 4D imaging, acquisition and analysis of 4D cardiac MRI images-A single, faster acquisition (8 to 15 minutes). |
| 2D magnetic resonance imaging | Sham comparator | Procedure: magnetic resonance imagingMRI, 2D imaging, acquisition and analysis of 2D cardiac MRI |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- - children from the age of 10 and above without any upper age limit;
- giving their informed consent for the study;
- with a corrected tetralogy of Fallot;
- sent for a follow-up imaging examination with endomyocardial fibrosis screening;
Key exclusion criteria (4 listed)
- - pregnant woman;
- children <10 years old;
- All contraindications inherent to MRI: (claustrophobia, ferromagnetic intracorporeal foreign bodies)
- Contraindication to contrast media injection (Gadolinium)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imagingAcquisition 4D Flow magnetic resonance Imaging-8 minutes | Procedure or surgery | 2D magnetic resonance imaging, 4D magnetic resonance imaging |
Primary outcome
Comparison of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI.
Time frame: 20 min
Assessment of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI : regurgitation volume (ml) and regurgitation fraction (%).
1 secondary outcome
Compare the evaluation of right ventricle volumes using 2D MRI and 4D Flow MRI.
Time frame: 20 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- 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.
Marc Antoine ISORNI, Doctor principal investigator
Hôpital Marie Lannelongue
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance imaging in people with Congenital Heart Disease, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
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 4 inclusion and 4 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 23 Jan 2020. 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 France. 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. Some participants in this study may receive a placebo. 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 Olaf Mercier, Professor (+33140948695, o.mercier@hml.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI. (time frame: 20 min). 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 23 Jan 2020.