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Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion

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ClinicalTrials.gov Identifier: NCT01100008
Recruitment Status : Completed
First Posted : April 8, 2010
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Pulmonary Hypertension Procedure: Magnetic resonance imaging (MRI)

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Study Start Date : September 2007
Primary Completion Date : September 2013
Study Completion Date : June 2014


Arms and Interventions

Arm Intervention/treatment
Experimental: Magnetic resonance imaging Procedure: Magnetic resonance imaging (MRI)
MRI cardiac and pulmonary with gadolinium


Outcome Measures

Primary Outcome Measures :
  1. Nuclear magnetic resonance imaging [ Time Frame: 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100008


Locations
France
Service de radiologie - Hôpital Rangueil
Toulouse, Midi-Pyrénées, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Valérie Chabbert, MD University Hospital, Toulouse
More Information

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01100008     History of Changes
Other Study ID Numbers: 06 042 02
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Toulouse:
Pulmonary arterial hypertension
cardiac MRI (magnetic resonance imaging)
severity
prognosis

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases