Differential Diagnosis of Pulmonary Hypertension With Automated Image Analysis

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

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Radiation: Thoracic computed tomography

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

• Study Contact: Name: Horst Olschewski, MD; Phone Number: +43-316-385-12183; Email: horst.olschewski@medunigraz.at

Study Locations

• Austria
  • Steiermark
    • Graz, Steiermark, Austria, 8010
      • Medical University Graz, Division of Pulmonology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Populations are recruited from the patients visiting the outpatient clinic for pulmonology of the Medical University of Graz.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Radiation: Thoracic computed tomography; Patients undergo contrast-enhanced thoracic computed tomography as part of their routine clinical 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.	Radiation: Thoracic computed tomography; Patients undergo contrast-enhanced thoracic computed tomography as part of their routine clinical 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.	Radiation: Thoracic computed tomography; Patients undergo contrast-enhanced thoracic computed tomography as part of their routine clinical 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.	Radiation: Thoracic computed tomography; Patients undergo contrast-enhanced thoracic computed tomography as part of their routine clinical 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.	Radiation: Thoracic computed tomography; Patients undergo contrast-enhanced thoracic computed tomography as part of their routine clinical 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.	Radiation: Thoracic computed tomography; Patients undergo contrast-enhanced thoracic computed tomography as part of their routine clinical 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.	Radiation: Thoracic computed tomography; Patients undergo contrast-enhanced thoracic computed tomography as part of their routine clinical work up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Ludwig Boltzmann Institute for Lung Vascular Research
• Investigators: Principal Investigator: Horst Olschewski, MD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 32-184 ex 19/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No