Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension

May 27, 2014 updated by: Olschewski, Horst, Prof. MD, Medical University of Graz

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.

Study Overview

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

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Stmk.
      • Graz, Stmk., Austria, 8036
        • Medical Unitersity Graz, University Clinic of Internal Medicine, Department of Pulmonology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at the MRI investigation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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