4D Velocity Mapping of the Heart in rTOF Patients

NCT ID: NCT02980614

Last Updated: 2018-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-27

Study Completion Date

2019-12-31

Brief Summary

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MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence.

Detailed Description

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MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence. The objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured using 4D MR-flow and standard 2D MR-flow in repaired Tetralogy of Fallot (rTOF) patients. The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery tree (PA flow =LeftPA flow +RightPA flow ? ).

Conditions

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Magnetic Resonance Imaging Tetralogy of Fallot

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Participants to 4D flow imaging

In addition to the standard clinical MR protocol, 2 added sequences:

4D MR sequence in cine mode 4D velocity mapping sequence

Group Type EXPERIMENTAL

4D flow imaging

Intervention Type DEVICE

To compare the quantification of pulmonary valve leakage by standard 2D flow MRI and 4D flow MRI by measuring the regurgitation fraction (ratio of retrograde blood flow to anterograde flow) in the pulmonary artery

Interventions

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4D flow imaging

To compare the quantification of pulmonary valve leakage by standard 2D flow MRI and 4D flow MRI by measuring the regurgitation fraction (ratio of retrograde blood flow to anterograde flow) in the pulmonary artery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Tetralogy of Fallot patients
* referred for clinical MRI examination
* ≥ 15 years

Exclusion Criteria

* Anyone with a classic contraindication to MRI
* Severe obesity
* Gadolinium chelate allergy
* \< 15 years
* counter-indication to MRI examination
* vulnerable person
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cedric Renard, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cedric Renard, MD

Role: CONTACT

+33 3 22 08 75 37

Facility Contacts

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Cedric Renard, MD

Role: primary

+33 3 22 08 75 37

Other Identifiers

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PI2016_843_0026

Identifier Type: -

Identifier Source: org_study_id

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