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
About this trial
This is an observational trial for Pulmonary Hypertension
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
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
NCT ID
NCT00575692
First Posted
December 17, 2007
Last Updated
May 27, 2014
Sponsor
Medical University of Graz
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
Learn more about this trial
Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension
We'll reach out to this number within 24 hrs