Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion

NCT ID: NCT01100008

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2014-06-30

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).

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Magnetic resonance imaging

Group Type: EXPERIMENTAL

Magnetic resonance imaging (MRI)

Intervention Type: PROCEDURE

MRI cardiac and pulmonary with gadolinium

Interventions

Magnetic resonance imaging (MRI)

MRI cardiac and pulmonary with gadolinium

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valérie Chabbert, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Service de radiologie - Hôpital Rangueil

Toulouse, Midi-Pyrénées, France

Countries

France

Other Identifiers

06 042 02

Identifier Type: -

Identifier Source: org_study_id