Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT01725763 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Medical University of Graz |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Ursula Reiter, PhDMichael Fuchsjäger, Prof. Dr. |
| Principal Investigator Affiliation | Medical Unitersity Graz, Department of Radiology, Division of General RadiologyMedical Unitersity Graz, Department of Radiology, Division of General Radiology |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Enrolling by invitation |
| Countries | Austria |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Pulmonary Hypertension, Elevated Mean Pulmonary Arterial Pressure, Normal Mean Pulmonary Arterial Pressure |
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