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NCT04782531 Clinical Trial

Variations of Portal Flow During the Respiratory Cycle in Healthy Volunteers

MRI Clinical Trial

— RESPIFLUX  

Official title:
Variations of Portal Flow During the Respiratory Cycle in Healthy Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04782531
Other study ID # PI2020_843_0150
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date June 2024

Study information
Verified date April 2024
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The analysis of portal vein blood flow is important when assessing the severity and progression of liver disease. It is important to understand normal liver regulation in order to appreciate the evaluation of the effect of treatment during the disease progression. The influence of respiration on hepatic hemodynamics is still poorly understood, although some studies have shown a significant impact. The purpose of this project is to quantify the blood flow variations in the portal vein at different positions during the respiratory cycle by using a fast MRI sequence and an Echo Planar (EPI) acquisition.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 12
Est. completion date June 2024
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 ans - Healthy subject without history of hepatic disease Exclusion Criteria: - history of hepatic pathology - pregnant woman - claustrophobia - major obesity - any contraindication to MRI exam

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• peripheral ECG
Subjects will be placed in supine position. The systematic use of a headset will reduce the noise inherent to the machine. A cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate.
• Standard MRI
Standard MRI examination using a torso coil consists of morphological and phase-contrast flow sequences(standard and EPI acquisitions).

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 flow rates variation between the fast sequence averaged values and the standard sequence flow rates variation between the fast sequence averaged values and the standard sequence during free breathing. 30 minutes
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