Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension (CMR-PH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01725763|
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2012
Last Update Posted : February 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Elevated Mean Pulmonary Arterial Pressure Normal Mean Pulmonary Arterial Pressure||Other: Cardiac MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2025|
60 minute Cardiac MRI
Other: Cardiac MRI
- blood flow patterns [ Time Frame: 2 years ]fluid dynamical properties of blood flow patterns in the heart and surrounding great vessels associated with ethiology of PH
- myocardial magnetic relaxation times [ Time Frame: 2 years ]left and right ventricular myocardial T1 times associated with ethiology of PH
- pulmonary ventilation and perfusion [ Time Frame: 2 years ]pulmonary ventilation and perfusion associated with ethiology of PH
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725763
|Medical Unitersity Graz, Department of Radiology, Division of General Radiology|
|Graz, Styria, Austria, 8036|
|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|