Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 3, 2012
March 29, 2014
December 2012
December 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01725763 on ClinicalTrials.gov Archive Site
  • 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
  • myocardial magnetic relaxation times [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    left and right venticular 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
Not Provided
Not Provided
 
Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension
Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Pulmonary Hypertension
  • Elevated Mean Pulmonary Arterial Pressure
  • Normal Mean Pulmonary Arterial Pressure
Other: Cardiac MRI
suspected PH
60 minute Cardiac MRI
Intervention: Other: Cardiac MRI
Reiter U, Reiter G, Kovacs G, Stalder AF, Gulsun MA, Greiser A, Olschewski H, Fuchsjäger 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
150
December 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01725763
CMR-12-PH
Yes
Ursula Reiter, Medical University of Graz
Medical University of Graz
Not Provided
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
Medical University of Graz
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP