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Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension, Ventricular Function, MR Phase Contrast Velocity Imaging

Status
Completed
Phase
Locations
Austria
Study Type
Observational
Intervention
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • MRI exclusion criteria

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

PulmoHypertension

Controls

Arm Description

Patients with suspected, latent or manifest pulmonary hypertension

Controls without history of cardiac or pulmonary diseases

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
December 17, 2007
Last Updated
May 27, 2014
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT00575692
Brief Title
Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension
Official Title
Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension
Study Type
Observational

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Patients with suspected, latent and manifest PH and controls are investigated by MRI according to the following protocol in breathhold or free breathing (depending on the patients' breath-hold abilities). In case of elevated Creatinin values, no contrast agent is applied. Planning of cardiac views: Planning of 2-chamber view, short axes view and 4-chamber view. Morphological overview: Transversal and coronal Haste images Left and right heart functional and valve evaluation: Cine 2-chamber imaging, Multi-slice cine 4-chamber imaging, Cine Left and Right ventricular outflow tract imaging and Multi-slice cine short axes imaging covering the left and right ventricle for evaluation of EDV, ESV, SV, EF, CO and muscle mass. Phase Contrast Imaging: Flow measurements in the aorta, the pulmonary artery and the heart. Perfusion measurement. Late enhancement measurement: Multi-slice short axes view, multi-slice 2-chamber view and multi-slice 4-chamber view.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Ventricular Function, MR Phase Contrast Velocity Imaging, Late Enhancement Patterns

7. Study Design

Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PulmoHypertension
Arm Description
Patients with suspected, latent or manifest pulmonary hypertension
Arm Title
Controls
Arm Description
Controls without history of cardiac or pulmonary diseases
Primary Outcome Measure Information:
Title
right ventricular function
Description
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)
Time Frame
at the MRI investigation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Controls without history of cardiac or pulmonary diseases Patients with suspected PH Patients with latent PH Patients with manifest PH Exclusion Criteria: MRI exclusion criteria
Study Population Description
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.
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabor Kovacs, MD
Organizational Affiliation
Medical Unitersity Graz, University Clinic of Internal Medicine, Department of Pulmonology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ursula Reiter, PhD
Organizational Affiliation
Medical Unitersity Graz, University Clinic of Radiology, Department of General Radiological Diagnostics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gert Reiter, PhD
Organizational Affiliation
Siemens Medical Austria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HOrst Olschewski, M.D.
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Unitersity Graz, University Clinic of Internal Medicine, Department of Pulmonology
City
Graz
State/Province
Stmk.
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
19808511
Citation
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.
Results Reference
result
PubMed Identifier
35990987
Citation
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.
Results Reference
derived
PubMed Identifier
32974687
Citation
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.
Results Reference
derived
PubMed Identifier
25372980
Citation
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.
Results Reference
derived

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Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension

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