Differential Diagnosis of Pulmonary Hypertension With Automated Image Analysis

Study Purpose

The aim of the study is to determine relevant morphologic parameters of the lung vasculature for the differentiation between different groups of patients with pulmonary hypertension (PH) by thoracic computer tomography (CT). In this pilot study patients undergoing right heart catheterization will be investigated by thoracic CT and special software to determine morphologic readouts. The investigators expect that using this non-invasive method, parameters relevant for the differentiation of the patients with PH can be determined.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
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.	Observational
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients with right-heart catheterization.

- Clinical indication for thoracic CT.

Exclusion Criteria:

- Pregnancy.

- Decreased kidney function.

- Intolerance to contrast material.

- Other standard CT contraindications

Trial Details

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.	NCT04329312
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.
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
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Horst Olschewski, MD
Principal Investigator Affiliation	Medical University of Graz
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Austria
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension

Additional Details

Pulmonary hypertension (PH) is defined as an elevated mean pressure in the pulmonary artery above 20mmHg determined at right-heart catheterization. Depending on the presentation and pathogenesis, patients are classified according to five main groups. A correct classification is crucial, since it is essential for the available therapy options. A promising non-invasive method to provide important hemodynamic and clinical Information is the fully-automatic analysis of thoracic computed tomography images. This method can yield a number of quantitative morphologic readouts of the lung vasculature and the parenchyma. This study aims to identify quantitative markers from the fully-automatic image analysis, which allow a discrimination between the various PH patient groups.

Arms & Interventions

Arms

: Pulmonary arterial hypertension (PAH)

The patients with PAH received an invasive right-heart catheterization and a thoracic CT scan as part of their routine work up.

: PH due to left-heart disease (PH-LHD)

The patients with PH-LHD received an invasive right-heart catheterization and a thoracic CT scan as part of their routine work up.

: Chronic thromboembolic pulmonary hypertension (CTEPH)

The patients with CTEPH received an invasive right-heart catheterization and a thoracic CT scan as part of their routine work up.

: PH due to emphysema (PH-LD-Emphys)

The patients with PH-LD-Emphys received an invasive right-heart catheterization and a thoracic CT scan as part of their routine work up.

: PH due to lung fibrosis (PH-LD-Fibr)

The patients with PH-LD-Fibr received an invasive right-heart catheterization and a thoracic CT scan as part of their routine work up.

: PH due to combined emphysema and fibrosis (PH-LD-CPFE)

The patients with PH-LD-CPFE received an invasive right-heart catheterization and a thoracic CT scan as part of their routine work up.

: No PH

The patients without PH received an invasive right-heart catheterization and a thoracic CT scan as part of their routine work up.

Interventions

Radiation: - Thoracic computed tomography

Patients undergo contrast-enhanced thoracic computed tomography as part of their routine clinical work up.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.