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

NCT01725763 | Enrolling By Invitation DMC

• 1 other identifier: CMR-12-PH
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• myocardial magnetic relaxation times

  2 years

• pulmonary ventilation and perfusion

  2 years

Study Arms (1)

suspected PH

OTHER

60 minute Cardiac MRI

Other: Cardiac MRI

Interventions

Cardiac MRI OTHER

suspected PH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

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

Graz, Styria, 8036, Austria

Location

Related Publications (7)

• 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.

  PMID: 24349224 RESULT

• 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.

  PMID: 25372980 RESULT

• 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.

  PMID: 26942293 RESULT

• 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.

  PMID: 32974687 RESULT

• 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.

  PMID: 35990987 RESULT

• 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.

  PMID: 35189283 RESULT

• 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.

  PMID: 27501792 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ursula Reiter, PhD

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

  PRINCIPAL INVESTIGATOR

• Michael Fuchsjäger, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2012
• First Posted: November 14, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

AU (1)