Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension (CMR-PH)

Pulmonary hypertension (PH) is a life-threatening cardiovascular disease characterized by pathological elevation of mean pulmonary arterial pressure (mPAP) >/= 25 mmHg at rest. mPAP < 20 mmHg is defined as normal, values in the range between 21-24 mmHg are described as "borderline PH" diagnosed by right heart catheterization. Based on the etiology, PH is assigned to 5 groups (WHO, Data Point, 2008), whereas classification of disease is an important prognostic and therapy-deciding criterion.

Cardiac magnetic resonance tomography (CMR) provides a reliable technique to estimate elevated mean pulmonary arterial pressure from period of existence of a vortical motion of blood flow in the main pulmonary artery. Vortex can be visualized in 3-dimensional vector field, particle trace and streamline representations and can be analysed with respect to vortex related measures (geometry of center, vortex formation, vorticity, propagation dynamics …). Furthermore T1-mapping and non-contrast enhanced lung perfusion/ventilation scans represent promising techniques for PH characterization.

Aim of this explorative study is to 1. analyse PH-associated blood flow characteristics in the heart and the surrounding great vessels with respect to the 5 groups of PH, and 2. investigate the hemodynamic state of "borderline PH" compared to normal mPAP and manifest PH by non-contrast CMR.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pulmonary Hypertension; Elevated Mean Pulmonary Arterial Pressure; Normal Mean Pulmonary Arterial Pressure
• Intervention / Treatment: Other: Cardiac MRI

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Medical Unitersity Graz, Department of Radiology, Division of General Radiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients with suspected or known PH scheduled for routine right-heart catheterization,
• ability to give informed consent.

Exclusion Criteria:

• General MR exclusion criteria eg. patients with metal devices or other magnetic material in or on the subjects body which will be hazardous for MR investigation (e.g. heart pace-maker, brain aneurysm clip, nerve stimulators, electrodes, penile implants, coloured contact lenses, patch to deliver medications through the skin, any metal implants as rods, joints, plates, pins, screws, nails or clips, embolization coil, or any metal fragments or shrapnel in the body),
• patients with tendency toward claustrophobia,
• hemodynamically unstable patients,
• pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: suspected PH; 60 minute Cardiac MRI	Other: Cardiac MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood flow patterns	fluid dynamical properties of blood flow patterns in the heart and surrounding great vessels associated with ethiology of PH	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
myocardial magnetic relaxation times	left and right ventricular myocardial T1 times associated with ethiology of PH	2 years
pulmonary ventilation and perfusion	pulmonary ventilation and perfusion associated with ethiology of PH	2 years

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Michael Fuchsjäger, Prof. Dr., Medical Unitersity Graz, Department of Radiology, Division of General Radiology; Principal Investigator: Ursula Reiter, PhD, Medical Unitersity Graz, Department of Radiology, Division of General Radiology

Publications and helpful links

General Publications

• Reiter U, Reiter G, Kovacs G, Stalder AF, Gulsun MA, Greiser A, Olschewski H, Fuchsjager M. Evaluation of elevated mean pulmonary arterial pressure based on magnetic resonance 4D velocity mapping: comparison of visualization techniques. PLoS One. 2013 Dec 12;8(12):e82212. doi: 10.1371/journal.pone.0082212. eCollection 2013.
• 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.
• Reiter U, Reiter G, Fuchsjager M. MR phase-contrast imaging in pulmonary hypertension. Br J Radiol. 2016 Jul;89(1063):20150995. doi: 10.1259/bjr.20150995. Epub 2016 Apr 6.
• Reiter G, Reiter U, Kovacs G, Adelsmayr G, Greiser A, Stalder AF, Olschewski H, Fuchsjager M. Counter-clockwise vortical blood flow in the main pulmonary artery in a patient with patent ductus arteriosus with pulmonary arterial hypertension: a cardiac magnetic resonance imaging case report. BMC Med Imaging. 2016 Aug 8;16(1):45. doi: 10.1186/s12880-016-0150-z.
• 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.
• 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.
• Krauter C, Reiter U, Kovacs G, Reiter C, Masana M, Olschewski H, Fuchsjager M, Stollberger R, Reiter G. Automated vortical blood flow-based estimation of mean pulmonary arterial pressure from 4D flow MRI. Magn Reson Imaging. 2022 May;88:132-141. doi: 10.1016/j.mri.2022.02.007. Epub 2022 Feb 18.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 3, 2012
• First Submitted That Met QC Criteria: November 13, 2012
• First Posted (Estimated): November 14, 2012

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: CMR-12-PH