NCT02980614

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 27, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

2.7 years

First QC Date

November 10, 2016

Last Update Submit

August 3, 2018

Conditions

Magnetic Resonance ImagingTetralogy of Fallot

Keywords

phase-contrast MRIblood flowvelocity mappingQuantitative MRICardiac imagingTetralogy of Fallot

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Right ventricular volume

    Day 0

  • Pulmonary arteries flows

    Day 0

Study Arms (1)

Participants to 4D flow imaging

EXPERIMENTAL

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

Interventions

4D flow imagingDEVICE

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

Participants to 4D flow imaging

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Cedric Renard, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cedric Renard, MD

CONTACT

+33 3 22 08 75 37renard.cedric@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

December 2, 2016

Study Start

March 27, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 6, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)