- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01100008
Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Midi-Pyrénées
-
Toulouse, Midi-Pyrénées, France, 31000
- Service de radiologie - Hôpital Rangueil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Magnetic resonance imaging
|
MRI cardiac and pulmonary with gadolinium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Inclusion ; 3rd month ; 12th month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Valérie Chabbert, MD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06 042 02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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