4D-flow Cardiac MRI to Assess Pulmonary Arterial Pressure in Pulmonary Hypertension (HTPFLUW)
Primary Purpose
Pulmonary Hypertension, Magnetic Resonance Imaging, Pulmonary Arterial Pressure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
4D-flow sequence
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Hypertension focused on measuring Pulmonary Hypertension, 4D-flow magnetic resonance imaging, mean pulmonary arterial pressure, right heart catheterization, echocardiography
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old,
- Patient referred for cardiac MRI who previously underwent right heart catheterization for pulmonary hypertension assessment,
- Affiliation to a social security program,
- Ability of the subject to understand and express opposition
Exclusion Criteria:
- Age <18 years old,
- Major obesity (> 140 kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70 cm,
- Person under guardianship or curators,
- Pregnant woman,
- Allergy to gadolinium chelates,
- Claustrophobia,
- Any contraindications to MRI
Sites / Locations
- CHU Amiens-Picardie
Outcomes
Primary Outcome Measures
Correlation coefficient between the values of mPAP (mmHg) and right heart catheterization rate.
mPAP is obtained by 4D flow MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT05103189
First Posted
October 21, 2021
Last Updated
July 18, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05103189
Brief Title
4D-flow Cardiac MRI to Assess Pulmonary Arterial Pressure in Pulmonary Hypertension
Acronym
HTPFLUW
Official Title
4D Flow Cardiac MRI Velocity Mapping in Patients With Pulmonary Hypertension: Estimation of Pulmonary Arterial Pressure and Comparison With Right Heart Catheterization and Doppler Echocardiography
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Due to radiation exposure and low but real risk of morbidity and mortality associated with right heart catheterization, non-invasive procedures to estimate mPAP are desired for the diagnosis of PH or to monitor treatment effectiveness. Echocardiography is used as a screening tool to estimate systolic pulmonary arterial pressure (sPAP), but due various limitations, this technique is not considered to be sufficiently accurate for the diagnosis of PH. The aim of 4D flow MRI is to evaluate the complete time-varying tridirectional velocity field in a volume of interest. It enables flow and velocity measurements in a vascular region of interest and visualization of vector plots of blood flow velocity fields. Previous studies have shown on the one hand, correlations between mPAP and hemodynamic parameters obtained by phase contrast MRI and, on the other hand, appearance of a vortical blood flow in the pulmonary artery in PH. More studies are required to confirm 4D MRI as a valuable tool for mPAP estimation in PH.
Following screening echocardiography, all patients will undergo right heart catheterization for PH assessment. Then, all patients will be referred for a complete cardiac MRI exam with the addition of a 4D Flow sequence (does not require supplementary injection of a contrast agent and does not extend the duration of the examination) followed promptly (within the same hour) by a Doppler-echocardiography. The data from each examination will be blindly interpreted from the results of the other one. No follow-up will be required for the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Magnetic Resonance Imaging, Pulmonary Arterial Pressure, Right Heart Catheterization, Echocardiography
Keywords
Pulmonary Hypertension, 4D-flow magnetic resonance imaging, mean pulmonary arterial pressure, right heart catheterization, echocardiography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
4D-flow sequence
Intervention Description
all patients will be referred for a complete cardiac MRI exam with the addition of a 4D Flow sequence (does not require supplementary injection of a contrast agent and does not extend the duration of the examination) followed promptly (within the same hour) by a Doppler-echocardiography.
Primary Outcome Measure Information:
Title
Correlation coefficient between the values of mPAP (mmHg) and right heart catheterization rate.
Description
mPAP is obtained by 4D flow MRI
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old,
Patient referred for cardiac MRI who previously underwent right heart catheterization for pulmonary hypertension assessment,
Affiliation to a social security program,
Ability of the subject to understand and express opposition
Exclusion Criteria:
Age <18 years old,
Major obesity (> 140 kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70 cm,
Person under guardianship or curators,
Pregnant woman,
Allergy to gadolinium chelates,
Claustrophobia,
Any contraindications to MRI
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
4D-flow Cardiac MRI to Assess Pulmonary Arterial Pressure in Pulmonary Hypertension
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