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

Primary Purpose

Pulmonary Hypertension, Elevated Mean Pulmonary Arterial Pressure, Normal Mean Pulmonary Arterial Pressure

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Cardiac MRI
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical Unitersity Graz, Department of Radiology, Division of General Radiology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

suspected PH

Arm Description

60 minute Cardiac MRI

Outcomes

Primary Outcome Measures

blood flow patterns
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
left and right ventricular myocardial T1 times associated with ethiology of PH
pulmonary ventilation and perfusion
pulmonary ventilation and perfusion associated with ethiology of PH

Full Information

First Posted
November 3, 2012
Last Updated
March 14, 2023
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT01725763
Brief Title
Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension
Acronym
CMR-PH
Official Title
Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2030 (Anticipated)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Elevated Mean Pulmonary Arterial Pressure, Normal Mean Pulmonary Arterial Pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
suspected PH
Arm Type
Other
Arm Description
60 minute Cardiac MRI
Intervention Type
Other
Intervention Name(s)
Cardiac MRI
Primary Outcome Measure Information:
Title
blood flow patterns
Description
fluid dynamical properties of blood flow patterns in the heart and surrounding great vessels associated with ethiology of PH
Time Frame
2 years
Secondary Outcome Measure Information:
Title
myocardial magnetic relaxation times
Description
left and right ventricular myocardial T1 times associated with ethiology of PH
Time Frame
2 years
Title
pulmonary ventilation and perfusion
Description
pulmonary ventilation and perfusion associated with ethiology of PH
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Reiter, PhD
Organizational Affiliation
Medical Unitersity Graz, Department of Radiology, Division of General Radiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Fuchsjäger, Prof. Dr.
Organizational Affiliation
Medical Unitersity Graz, Department of Radiology, Division of General Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Unitersity Graz, Department of Radiology, Division of General Radiology
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Citations:
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
background
PubMed Identifier
24349224
Citation
Reiter U, Reiter G, Kovacs G, Stalder AF, Gulsun MA, Greiser A, Olschewski H, Fuchsjager 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.
Results Reference
result
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
result
PubMed Identifier
26942293
Citation
Reiter U, Reiter G, Fuchsjager M. MR phase-contrast imaging in pulmonary hypertension. Br J Radiol. 2016 Jul;89(1063):20150995. doi: 10.1259/bjr.20150995. Epub 2016 Apr 6.
Results Reference
result
PubMed Identifier
27501792
Citation
Reiter G, Reiter U, Kovacs G, Adelsmayr G, Greiser A, Stalder AF, Olschewski H, Fuchsjager M. Counter-clockwise vortical blood flow in the main pulmonary artery in a patient with patent ductus arteriosus with pulmonary arterial hypertension: a cardiac magnetic resonance imaging case report. BMC Med Imaging. 2016 Aug 8;16(1):45. doi: 10.1186/s12880-016-0150-z.
Results Reference
derived

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

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