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Trial record 2 of 6 for:    OLAF MERCIER

Imaging by 4 DFlow in Patients With Tetralogy of Fallot (4DFlowFallot)

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ClinicalTrials.gov Identifier: NCT03542968
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

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).


Condition or disease Intervention/treatment Phase
Congenital Heart Disease Procedure: magnetic resonance imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging by 4 DFlow in Patients With Tetralogy of Fallot
Actual Study Start Date : October 12, 2017
Actual Primary Completion Date : October 11, 2019
Estimated Study Completion Date : April 11, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 4D magnetic resonance imaging
MRI, 4D imaging, acquisition and analysis of 4D cardiac MRI images-A single, faster acquisition (8 to 15 minutes).
Procedure: magnetic resonance imaging
Acquisition 4D Flow magnetic resonance Imaging-8 minutes

Sham Comparator: 2D magnetic resonance imaging
MRI, 2D imaging, acquisition and analysis of 2D cardiac MRI
Procedure: magnetic resonance imaging
Acquisition 4D Flow magnetic resonance Imaging-8 minutes




Primary Outcome Measures :
  1. 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 (%).


Secondary Outcome Measures :
  1. Compare the evaluation of right ventricle volumes using 2D MRI and 4D Flow MRI. [ Time Frame: 20 min ]
    Assessment of the end-diastolic and end-systolic right ventricle volumes using 2D MRI and 4D Flow MRI (ml).



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542968


Contacts
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Contact: Olaf Mercier, Professor +33140948695 o.mercier@hml.fr

Locations
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France
Hôpital Marie Lannelongue Recruiting
Le Plessis-Robinson, France, 92350
Contact: Marc antoine ISORNI    +33140948554    ma-isorni@hml.fr   
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Investigators
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Principal Investigator: Marc Antoine ISORNI, Doctor Hôpital Marie Lannelongue
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Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT03542968    
Other Study ID Numbers: 2017-A01482-51
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Chirurgical Marie Lannelongue:
Congenital heart disease
Tetralogy of Fallot
Imaging by 4D Flow,
Magnetic resonance imaging
Prevention of ventricular dysfunction
Additional relevant MeSH terms:
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Heart Diseases
Tetralogy of Fallot
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities