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

August 3, 2018 updated by: Centre Hospitalier Universitaire, Amiens

Cardiac 4D MR Velocity Mapping in Repaired Tetralogy of Fallot Patients: Evaluation of Pulmonary Regurgitant Fraction and Ventricular Volume

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 ? ).

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens
        • Contact:
        • Sub-Investigator:
          • Amel Mathiron, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regurgitant fraction comparison
Time Frame: Day 0
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.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right ventricular volume
Time Frame: Day 0
The secondary objective is to compare the right ventricular volumes measured using the 4D prototype and the standard steady-state free precession sequences.
Day 0
Pulmonary arteries flows
Time Frame: Day 0
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 ? ).
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Actual)

August 6, 2018

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2016_843_0026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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