Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion

Not Applicable

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Procedure: Magnetic resonance imaging (MRI)

• Registration Number: NCT01100008
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Pulmonary hypertension is a rare severe disease leading to cardiac insufficiency. Treatment depends on the severity of the disease.

This study evaluates cardiac MRI for the assessment of pulmonary hypertension severity and identification of parameters useful for the follow-up in order to adapt the medical treatment to status of the patient.

Evaluate if cardiac MRI can obviate right cardiac catheterization in the follow-up.

Detailed Description

Thirty patients will be enrolled and followed for 1 year after their inclusion.

Cardiac MRI will be performed at inclusion and at 3 months and 12 months. At the same periods, echocardiography and right heart catheterization will be performed too.

Morphological and functional parameters will be studied with MRI and correlated to invasive parameters and echocardiography too.

Morphological parameters are: volumes, cardiac cavities areas and ratios and position of the interventricular septum. Functional parameters are: ejection fractions of right and left cavities, flow in pulmonary artery, across mitral and tricuspid valves, temporal measurements in the pulmonary artery and auriculoventricular valves.

The invasive measurements are considered as the gold standard for this study. The classification of the severity is defined according to the parameters from right cardiac catheterization (4 grades with severity increasing between 1 and 4).

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-08
• Primary Completion: 2013-09
• Study Completion: 2014-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Adults patients with pulmonary hypertension without specific treatment at inclusion
• Etiologies include chronic embolic disease, systemic fibrosis, Gougerot Sjogren, drug induced hypertension, primary hypertension.
• informed consent
• affiliated to medical insurance.

Exclusion Criteria

• Left cardiac disease responsible for pulmonary hypertension, congenital cardiopathies
• Pulmonary functional tests with important impairment (decrease in TPCmore than 30%, decrease In VEMS more than 30%
• Child
• pregnancy
• contraindications to MRI
• without informed consent
• without insurance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetic resonance imaging	Magnetic resonance imaging (MRI)	-

Primary Outcome Measures

Name	Time	Method
Nuclear magnetic resonance imaging	Inclusion ; 3rd month ; 12th month	Correlation of cardiac results from the first MRI (Magnetic Resonance Imaging) to invasive measurements from the first or initial right heart catheterization and to echocardiography to know if cardiac MRI is able to predict severity of the disease

Trial Locations

Locations (1)

Service de radiologie - Hôpital Rangueil; 🇫🇷 Toulouse, Midi-Pyrénées, France