Clinical trial NCT00575692: Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension
Official title: Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Ventricular Function
MR Phase Contrast Velocity Imaging
Late Enhancement Patterns
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: right ventricular function
timeFrame: at the MRI investigation
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical Unitersity Graz, University Clinic of Internal Medicine, Department of Pulmonology
state: Stmk.
Study officials:
affiliation: Medical Unitersity Graz, University Clinic of Internal Medicine, Department of Pulmonology
name: Gabor Kovacs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Unitersity Graz, University Clinic of Radiology, Department of General Radiological Diagnostics
name: Ursula Reiter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Siemens Medical Austria
name: Gert Reiter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Graz
name: HOrst Olschewski, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reiter G, Reiter U, Kovacs G, Kainz B, Schmidt K, Maier R, Olschewski H, Rienmueller R. Magnetic resonance-derived 3-dimensional blood flow patterns in the main pulmonary artery as a marker of pulmonary hypertension and a measure of elevated mean pulmonary arterial pressure. Circ Cardiovasc Imaging. 2008 Jul;1(1):23-30. doi: 10.1161/CIRCIMAGING.108.780247.
citation: Reiter G, Kovacs G, Reiter C, Schmidt A, Fuchsjager M, Olschewski H, Reiter U. Left atrial acceleration factor as a magnetic resonance 4D flow measure of mean pulmonary artery wedge pressure in pulmonary hypertension. Front Cardiovasc Med. 2022 Aug 3;9:972142. doi: 10.3389/fcvm.2022.972142. eCollection 2022.
citation: Reiter U, Kovacs G, Reiter C, Krauter C, Nizhnikava V, Fuchsjager M, Olschewski H, Reiter G. MR 4D flow-based mean pulmonary arterial pressure tracking in pulmonary hypertension. Eur Radiol. 2021 Apr;31(4):1883-1893. doi: 10.1007/s00330-020-07287-6. Epub 2020 Sep 24.
citation: Reiter G, Reiter U, Kovacs G, Olschewski H, Fuchsjager M. Blood flow vortices along the main pulmonary artery measured with MR imaging for diagnosis of pulmonary hypertension. Radiology. 2015 Apr;275(1):71-9. doi: 10.1148/radiol.14140849. Epub 2014 Nov 5.