Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic resonance imaging (MRI)
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Hypertension focused on measuring Pulmonary arterial hypertension, cardiac MRI (magnetic resonance imaging), severity, prognosis
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
Sites / Locations
- Service de radiologie - Hôpital Rangueil
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Magnetic resonance imaging
Arm Description
Outcomes
Primary Outcome Measures
Nuclear magnetic resonance imaging
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01100008
First Posted
March 1, 2010
Last Updated
March 11, 2016
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT01100008
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary arterial hypertension, cardiac MRI (magnetic resonance imaging), severity, prognosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnetic resonance imaging
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Magnetic resonance imaging (MRI)
Intervention Description
MRI cardiac and pulmonary with gadolinium
Primary Outcome Measure Information:
Title
Nuclear magnetic resonance imaging
Description
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
Time Frame
Inclusion ; 3rd month ; 12th month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Chabbert, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de radiologie - Hôpital Rangueil
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion
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