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

Pulmonary Hypertension Clinical Trial

— CMR-PH  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01725763
• Other study ID #: CMR-12-PH
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2030

Study information

• Verified date: November 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elevated Mean Pulmonary Arterial Pressure
• Hypertension
• Hypertension, Pulmonary
• Normal Mean Pulmonary Arterial Pressure
• Pulmonary Hypertension

Intervention

Other:
• Cardiac MRI

Locations

Country	Name	City	State
Austria	Medical Unitersity Graz, Department of Radiology, Division of General Radiology	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (6)

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: 10.1 — View 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;9:97 — View 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. — View 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 — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	myocardial magnetic relaxation times	left and right ventricular myocardial T1 times associated with ethiology of PH	2 years
Secondary	pulmonary ventilation and perfusion	pulmonary ventilation and perfusion associated with ethiology of PH	2 years