Differential Diagnosis of Pulmonary Hypertension With Automated Image Analysis

NCT04329312 | Terminated

• 1 other identifier: 32-184 ex 19/20
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (7)

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

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

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

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

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

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

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

Interventions

Thoracic computed tomography RADIATION

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

Chronic thromboembolic pulmonary hypertension (CTEPH); No PH; PH due to combined emphysema and fibrosis (PH-LD-CPFE); PH due to emphysema (PH-LD-Emphys); PH due to left-heart disease (PH-LHD); PH due to lung fibrosis (PH-LD-Fibr); Pulmonary arterial hypertension (PAH)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with right-heart catheterization
• Clinical indication for thoracic CT

You may not qualify if:

• Pregnancy
• Decreased kidney function
• Intolerance to contrast material
• Other standard CT contraindications

Sponsors & Collaborators

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

Study Sites (1)

Medical University Graz, Division of Pulmonology

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Horst Olschewski, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: June 15, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)