Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 8 for:    cardioflux

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02980614
Recruitment Status : Unknown
Verified August 2018 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was:  Recruiting
First Posted : December 2, 2016
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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

Condition or disease Intervention/treatment Phase
Magnetic Resonance Imaging Tetralogy of Fallot Device: 4D flow imaging Not Applicable

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 ? ).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cardiac 4D MR Velocity Mapping in Repaired Tetralogy of Fallot Patients: Evaluation of Pulmonary Regurgitant Fraction and Ventricular Volume
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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 ? ).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02980614


Contacts
Layout table for location contacts
Contact: Cedric Renard, MD +33 3 22 08 75 37 renard.cedric@chu-amiens.fr

Locations
Layout table for location information
France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Cedric Renard, MD    +33 3 22 08 75 37    renard.cedric@chu-amiens.fr   
Sub-Investigator: Amel Mathiron, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Layout table for investigator information
Principal Investigator: Cedric Renard, MD CHU Amiens
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02980614    
Other Study ID Numbers: PI2016_843_0026
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
phase-contrast MRI
blood flow
velocity mapping
Quantitative MRI
Cardiac imaging
Tetralogy of Fallot
Additional relevant MeSH terms:
Layout table for MeSH terms
Tetralogy of Fallot
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities