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Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01100008
First received: March 1, 2010
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Pulmonary Hypertension
 Procedure: Magnetic resonance imaging (MRI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Nuclear magnetic resonance imaging [ Time Frame: Inclusion ; 3rd month ; 12th month ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: September 2007
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnetic resonance imaging Procedure: Magnetic resonance imaging (MRI)
MRI cardiac and pulmonary with gadolinium

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01100008     History of Changes
Other Study ID Numbers: 06 042 02
Study First Received: March 1, 2010
Last Updated: January 22, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013