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NCT04329312 Clinical Trial

Differential Diagnosis of Pulmonary Hypertension With Automated Image Analysis

Pulmonary Hypertension Clinical Trial

Official title:
Differential Diagnosis of Pulmonary Hypertension With Automated Image Analysis - a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04329312
Other study ID # 32-184 ex 19/20
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 15, 2020
Est. completion date October 1, 2021

Study information
Verified date January 2024
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Terminated
Enrollment 23
Est. completion date October 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Austria Medical University Graz, Division of Pulmonology Graz Steiermark

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Graz Ludwig Boltzmann Institute for Lung Vascular Research

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lung vessel morphology Quantitative measures of lung vessel morphology based on automated CT image analysis based on artery-vein separation and vessel segmentation, which allow differentiation between the different groups of PH 1 day
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