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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
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 1, 2010
Last Updated
March 11, 2016
Sponsor
University Hospital, Toulouse
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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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