Differential Diagnosis of Pulmonary Hypertension With Automated Image Analysis

NCT ID: NCT04329312

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Thoracic computed tomography

Intervention Type RADIATION

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.

Thoracic computed tomography

Intervention Type RADIATION

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.

Thoracic computed tomography

Intervention Type RADIATION

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.

Thoracic computed tomography

Intervention Type RADIATION

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.

Thoracic computed tomography

Intervention Type RADIATION

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.

Thoracic computed tomography

Intervention Type RADIATION

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.

Thoracic computed tomography

Intervention Type RADIATION

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

Interventions

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Thoracic computed tomography

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig Boltzmann Institute for Lung Vascular Research

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Horst Olschewski, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University Graz, Division of Pulmonology

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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32-184 ex 19/20

Identifier Type: -

Identifier Source: org_study_id

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