search
Back to results

4D Velocity Mapping of the Heart in rTOF Patients (CARDIOFLUX)

Primary Purpose

Magnetic Resonance Imaging, Tetralogy of Fallot

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
4D flow imaging
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Magnetic Resonance Imaging focused on measuring phase-contrast MRI, blood flow, velocity mapping, Quantitative MRI, Cardiac imaging, Tetralogy of Fallot

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants to 4D flow imaging

Arm Description

In addition to the standard clinical MR protocol, 2 added sequences: 4D MR sequence in cine mode 4D velocity mapping sequence

Outcomes

Primary Outcome Measures

Regurgitant fraction comparison
The primary objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured with 4D MR-flow and standard 2D MR-flow.

Secondary Outcome Measures

Right ventricular volume
The secondary objective is to compare the right ventricular volumes measured using the 4D prototype and the standard steady-state free precession sequences.
Pulmonary arteries flows
The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery (PA) tree (PA flow =LeftPA flow +RightPA flow ? ).

Full Information

First Posted
November 10, 2016
Last Updated
August 3, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
search

1. Study Identification

Unique Protocol Identification Number
NCT02980614
Brief Title
4D Velocity Mapping of the Heart in rTOF Patients
Acronym
CARDIOFLUX
Official Title
Cardiac 4D MR Velocity Mapping in Repaired Tetralogy of Fallot Patients: Evaluation of Pulmonary Regurgitant Fraction and Ventricular Volume
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence.
Detailed Description
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 ? ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnetic Resonance Imaging, Tetralogy of Fallot
Keywords
phase-contrast MRI, blood flow, velocity mapping, Quantitative MRI, Cardiac imaging, Tetralogy of Fallot

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants to 4D flow imaging
Arm Type
Experimental
Arm Description
In addition to the standard clinical MR protocol, 2 added sequences: 4D MR sequence in cine mode 4D velocity mapping sequence
Intervention Type
Device
Intervention Name(s)
4D flow imaging
Intervention Description
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
Primary Outcome Measure Information:
Title
Regurgitant fraction comparison
Description
The primary objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured with 4D MR-flow and standard 2D MR-flow.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Right ventricular volume
Description
The secondary objective is to compare the right ventricular volumes measured using the 4D prototype and the standard steady-state free precession sequences.
Time Frame
Day 0
Title
Pulmonary arteries flows
Description
The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery (PA) tree (PA flow =LeftPA flow +RightPA flow ? ).
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cedric Renard, MD
Phone
+33 3 22 08 75 37
Email
renard.cedric@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cedric Renard, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cedric Renard, MD
Phone
+33 3 22 08 75 37
Email
renard.cedric@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Amel Mathiron, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

4D Velocity Mapping of the Heart in rTOF Patients

We'll reach out to this number within 24 hrs