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OpenTrials
Completed

NCT Number: NCT01100008

Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de radiologie - Hôpital Rangueil

Toulouse, Midi-Pyrénées, 31000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Procedure

MRI cardiac and pulmonary with gadolinium

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2013
Study completion
2014
First posted
Apr 8, 2010
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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