Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion

Descriptive Information
Brief Title † Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion
Official Title † Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion: Its Role in the Diagnosis of the Severity of Pulmonary Hypertension in Adults and in the Follow-up. Preliminary Study.
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 Phase N/A
Study Type † Interventional
Study Design † Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary Outcome Measure † Nuclear magnetic resonance imaging
Secondary Outcome Measure †
Condition † Pulmonary Hypertension
Intervention † ProcedureMagnetic resonance imaging (MRI)
Study Arms / Comparison Groups Magnetic resonance imaging
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 29
Start Date † September 2007
Completion Date June 2014
Primary Completion Date September 2013
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
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † France
Administrative Information
NCT ID † NCT01100008
Organization ID 06 042 02
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † University Hospital, Toulouse
Collaborators ††
Investigators † Principal Investigator: Valérie Chabbert, MD, University Hospital, Toulouse
Information Provided By
Verification Date June 2014
First Received Date † March 1, 2010
Last Updated Date June 11, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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