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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02980614
Other study ID # PI2016_843_0026
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 27, 2017
Est. completion date December 2019

Study information

Verified date August 2018
Source Centre Hospitalier Universitaire, Amiens
Contact Cedric Renard, MD
Phone +33 3 22 08 75 37
Email renard.cedric@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 ? ).


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 0
Secondary 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. Day 0
Secondary 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 ? ). Day 0
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