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

Not Applicable

• Conditions: Pulmonary Hypertension; Normal Mean Pulmonary Arterial Pressure; Elevated Mean Pulmonary Arterial Pressure
• Interventions: Other: Cardiac MRI

• Registration Number: NCT01725763
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-03
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-14
• Study Start: 2012-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
suspected PH	Cardiac MRI	60 minute Cardiac MRI

Primary Outcome Measures

Name	Time	Method
blood flow patterns	2 years	fluid dynamical properties of blood flow patterns in the heart and surrounding great vessels associated with ethiology of PH

Secondary Outcome Measures

Name	Time	Method
pulmonary ventilation and perfusion	2 years	pulmonary ventilation and perfusion associated with ethiology of PH
myocardial magnetic relaxation times	2 years	left and right ventricular myocardial T1 times associated with ethiology of PH

Trial Locations

Locations (1)

Medical Unitersity Graz, Department of Radiology, Division of General Radiology; 🇦🇹 Graz, Styria, Austria