Clinical trial NCT03542968: Imaging by 4 DFlow in Patients With Tetralogy of Fallot
Official title: Imaging by 4 DFlow in Patients With Tetralogy of Fallot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Congenital heart disease
Tetralogy of Fallot
Imaging by 4D Flow,
Magnetic resonance imaging
Prevention of ventricular dysfunction
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* - 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;

Exclusion Criteria:

* - pregnant woman;
* children \<10 years old;
* All contraindications inherent to MRI: (claustrophobia, ferromagnetic intracorporeal foreign bodies)
* Contraindication to contrast media injection (Gadolinium)

Primary outcomes:
measure: Comparison of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI.
timeFrame: 20 min
Secondary outcomes:
measure: Compare the evaluation of right ventricle volumes using 2D MRI and 4D Flow MRI.
timeFrame: 20 min
Other outcomes:
Locations:
city: Le Plessis-Robinson
country: France
facility: Hôpital Marie Lannelongue
Study officials:
affiliation: Hôpital Marie Lannelongue
name: Marc Antoine ISORNI, Doctor
role: PRINCIPAL_INVESTIGATOR
References: