Differential Diagnosis of Pulmonary Hypertension With Automated Image Analysis

Sponsor
Medical University of Graz (Other)
Overall Status
Recruiting
CT.gov ID
NCT04329312
Collaborator
Ludwig Boltzmann Institute for Lung Vascular Research (Other)
70
1
24
2.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Differential Diagnosis of Pulmonary Hypertension With Automated Image Analysis - a Pilot Study
Actual Study Start Date :
Jun 15, 2020
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Jun 15, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Lung vessel morphology [1 day]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University Graz, Division of Pulmonology Graz Steiermark Austria 8010

Sponsors and Collaborators

  • Medical University of Graz
  • Ludwig Boltzmann Institute for Lung Vascular Research

Investigators

  • Principal Investigator: Horst Olschewski, MD, Medical University of Graz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT04329312
Other Study ID Numbers:
  • 32-184 ex 19/20
First Posted:
Apr 1, 2020
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021