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

NCT ID: NCT01725763

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2030-12-31

Brief 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.

Conditions

Pulmonary Hypertension; Elevated Mean Pulmonary Arterial Pressure; Normal Mean Pulmonary Arterial Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

suspected PH

60 minute Cardiac MRI

Group Type: OTHER

Cardiac MRI

Intervention Type: OTHER

Interventions

Cardiac MRI

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• patients with tendency toward claustrophobia,
• hemodynamically unstable patients,
• pregnancy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Ursula Reiter

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ursula Reiter, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Unitersity Graz, Department of Radiology, Division of General Radiology

Michael Fuchsjäger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical Unitersity Graz, Department of Radiology, Division of General Radiology

Locations

Medical Unitersity Graz, Department of Radiology, Division of General Radiology

Graz, Styria, Austria

Countries

Austria

References

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.

Reference Type: RESULT

PMID: 24349224 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25372980 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26942293 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32974687 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35990987 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35189283 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27501792 (View on PubMed)

Other Identifiers

CMR-12-PH

Identifier Type: -

Identifier Source: org_study_id