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Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT00575692
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Olschewski, Horst, Prof. MD, Medical University of Graz

Brief Summary:

The aim of the present study is to identify changes in the cardiovascular system in patients with pulmonary hypertension (PH) by magnetic resonance imaging (MRI). MRI is accepted as golden standard method for the evaluation of left and right ventricular morphology and function.

All patients who showed elevated pulmonary pressure in the right heart catheter investigation are assigned to MRI. Parameters derived from MRI are included in the clinical and therapeutic decisions. Well established as well as new MRI parameters are evaluated and compared to the results of right heart catheter. Further age-matched controls without known cardiac or pulmonary disease are investigated by native MRI.


Condition or disease
Pulmonary Hypertension Ventricular Function MR Phase Contrast Velocity Imaging Late Enhancement Patterns

Detailed Description:

Patients with suspected, latent and manifest PH and controls are investigated by MRI according to the following protocol in breathhold or free breathing (depending on the patients' breath-hold abilities). In case of elevated Creatinin values, no contrast agent is applied.

  • Planning of cardiac views: Planning of 2-chamber view, short axes view and 4-chamber view.
  • Morphological overview: Transversal and coronal Haste images
  • Left and right heart functional and valve evaluation: Cine 2-chamber imaging, Multi-slice cine 4-chamber imaging, Cine Left and Right ventricular outflow tract imaging and Multi-slice cine short axes imaging covering the left and right ventricle for evaluation of EDV, ESV, SV, EF, CO and muscle mass.
  • Phase Contrast Imaging: Flow measurements in the aorta, the pulmonary artery and the heart.
  • Perfusion measurement.
  • Late enhancement measurement: Multi-slice short axes view, multi-slice 2-chamber view and multi-slice 4-chamber view.

Study Type : Observational
Actual Enrollment : 240 participants
Official Title: Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension
Study Start Date : December 2006
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
PulmoHypertension
Patients with suspected, latent or manifest pulmonary hypertension
Controls
Controls without history of cardiac or pulmonary diseases



Primary Outcome Measures :
  1. right ventricular function [ Time Frame: at the MRI investigation ]
    right ventricular end-diastolic volume (EDV), right ventricular end-systolic volume (ESV), right ventricular stroke volume (SV), right ventricular ejection fraction (EF), right ventricular cardiac output (CO), right ventricular muscle mass (RVMM)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Cardiac MR is recommended to all patients with suspected, latent and manifest PH who are investigated by right heat catheter in the Department of Pulmonology. Patients with pacemaker, agoraphobia or other standard MR contraindications are excluded from the study.
Criteria

Inclusion Criteria:

  • Controls without history of cardiac or pulmonary diseases
  • Patients with suspected PH
  • Patients with latent PH
  • Patients with manifest PH

Exclusion Criteria:

  • MRI exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575692


Locations
Austria
Medical Unitersity Graz, University Clinic of Internal Medicine, Department of Pulmonology
Graz, Stmk., Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Gabor Kovacs, MD Medical Unitersity Graz, University Clinic of Internal Medicine, Department of Pulmonology
Principal Investigator: Ursula Reiter, PhD Medical Unitersity Graz, University Clinic of Radiology, Department of General Radiological Diagnostics
Principal Investigator: Gert Reiter, PhD Siemens Medical Austria
Principal Investigator: HOrst Olschewski, M.D. Medical University of Graz

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Olschewski, Horst, Prof. MD, Univ.-Prof. Dr., Medical University of Graz
ClinicalTrials.gov Identifier: NCT00575692     History of Changes
Other Study ID Numbers: PH-06-CMR-01
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases