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Clinical Trials/NCT01725763
NCT01725763
Enrolling By Invitation
Not Applicable

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

Medical University of Graz1 site in 1 country150 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Hypertension
Sponsor
Medical University of Graz
Enrollment
150
Locations
1
Primary Endpoint
blood flow patterns
Status
Enrolling By Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
December 2030
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Medical University of Graz
Responsible Party
Principal Investigator
Principal Investigator

Ursula Reiter

Principal Investigator

Medical University of Graz

Eligibility Criteria

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.

Outcomes

Primary Outcomes

blood flow patterns

Time Frame: 2 years

fluid dynamical properties of blood flow patterns in the heart and surrounding great vessels associated with ethiology of PH

Secondary Outcomes

  • pulmonary ventilation and perfusion(2 years)
  • myocardial magnetic relaxation times(2 years)

Study Sites (1)

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