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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ursula Reiter, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01725763
First received: November 3, 2012
Last updated: March 29, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Pulmonary Hypertension
Elevated Mean Pulmonary Arterial Pressure
Normal Mean Pulmonary Arterial Pressure
Other: Cardiac MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • blood flow patterns [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    fluid dynamical properties of blood flow patterns in the heart and surrounding great vessels associated with ethiology of PH


Secondary Outcome Measures:
  • myocardial magnetic relaxation times [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    left and right ventricular myocardial T1 times associated with ethiology of PH

  • pulmonary ventilation and perfusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    pulmonary ventilation and perfusion associated with ethiology of PH


Estimated Enrollment: 150
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
suspected PH
60 minute Cardiac MRI
Other: Cardiac MRI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725763

Locations
Austria
Medical Unitersity Graz, Department of Radiology, Division of General Radiology
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: 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
  More Information

Publications:
Responsible Party: Ursula Reiter, Principal Investigator, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01725763     History of Changes
Other Study ID Numbers: CMR-12-PH
Study First Received: November 3, 2012
Last Updated: March 29, 2014
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014