NCT00575692

Brief Summary

The aim of the present study is to identify changes in the cardiovascular system in patients with pulmonary hypertension (PH) by magnetic resonance imaging (MRI). MRI is accepted as golden standard method for the evaluation of left and right ventricular morphology and function. All patients who showed elevated pulmonary pressure in the right heart catheter investigation are assigned to MRI. Parameters derived from MRI are included in the clinical and therapeutic decisions. Well established as well as new MRI parameters are evaluated and compared to the results of right heart catheter. Further age-matched controls without known cardiac or pulmonary disease are investigated by native MRI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

7 years

First QC Date

December 17, 2007

Last Update Submit

May 27, 2014

Conditions

Pulmonary HypertensionVentricular FunctionMR Phase Contrast Velocity ImagingLate Enhancement Patterns

Outcome Measures

Primary Outcomes (1)

  • right ventricular function

    right ventricular end-diastolic volume (EDV), right ventricular end-systolic volume (ESV), right ventricular stroke volume (SV), right ventricular ejection fraction (EF), right ventricular cardiac output (CO), right ventricular muscle mass (RVMM)

    at the MRI investigation

Study Arms (2)

PulmoHypertension

Patients with suspected, latent or manifest pulmonary hypertension

Controls

Controls without history of cardiac or pulmonary diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cardiac MR is recommended to all patients with suspected, latent and manifest PH who are investigated by right heat catheter in the Department of Pulmonology. Patients with pacemaker, agoraphobia or other standard MR contraindications are excluded from the study.

You may qualify if:

  • Controls without history of cardiac or pulmonary diseases
  • Patients with suspected PH
  • Patients with latent PH
  • Patients with manifest PH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Unitersity Graz, University Clinic of Internal Medicine, Department of Pulmonology

Graz, Stmk., 8036, Austria

Location

Related Publications (4)

  • Reiter G, Reiter U, Kovacs G, Kainz B, Schmidt K, Maier R, Olschewski H, Rienmueller R. Magnetic resonance-derived 3-dimensional blood flow patterns in the main pulmonary artery as a marker of pulmonary hypertension and a measure of elevated mean pulmonary arterial pressure. Circ Cardiovasc Imaging. 2008 Jul;1(1):23-30. doi: 10.1161/CIRCIMAGING.108.780247.

    PMID: 19808511RESULT

  • 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: 35990987DERIVED

  • 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: 32974687DERIVED

  • 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: 25372980DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Gabor Kovacs, MD

    Medical Unitersity Graz, University Clinic of Internal Medicine, Department of Pulmonology

    PRINCIPAL INVESTIGATOR

  • Ursula Reiter, PhD

    Medical Unitersity Graz, University Clinic of Radiology, Department of General Radiological Diagnostics

    PRINCIPAL INVESTIGATOR

  • Gert Reiter, PhD

    Siemens Medical Austria

    PRINCIPAL INVESTIGATOR

  • HOrst Olschewski, M.D.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr.

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 18, 2007

Study Start

December 1, 2006

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

AU(1)