Imaging by 4 DFlow in Patients With Tetralogy of Fallot
4DFlowFallot
1 other identifier
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2017
CompletedFirst Submitted
Initial submission to the registry
May 4, 2018
CompletedFirst Posted
Study publicly available on registry
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2020
CompletedJanuary 23, 2020
June 1, 2019
2 years
May 4, 2018
January 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (%).
20 min
Secondary Outcomes (1)
Compare the evaluation of right ventricle volumes using 2D MRI and 4D Flow MRI.
20 min
Study Arms (2)
4D magnetic resonance imaging
EXPERIMENTALMRI, 4D imaging, acquisition and analysis of 4D cardiac MRI images-A single, faster acquisition (8 to 15 minutes).
2D magnetic resonance imaging
SHAM COMPARATORMRI, 2D imaging, acquisition and analysis of 2D cardiac MRI
Interventions
Acquisition 4D Flow magnetic resonance Imaging-8 minutes
Eligibility Criteria
You may qualify if:
- \- 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;
You may not qualify if:
- \- pregnant woman;
- children \<10 years old;
- All contraindications inherent to MRI: (claustrophobia, ferromagnetic intracorporeal foreign bodies)
- Contraindication to contrast media injection (Gadolinium)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Antoine ISORNI, Doctor
Hôpital Marie Lannelongue
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2018
First Posted
June 1, 2018
Study Start
October 12, 2017
Primary Completion
October 11, 2019
Study Completion
April 11, 2020
Last Updated
January 23, 2020
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share