Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography

Not Applicable

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Radiation: Dual-energy computed tomography investigation

• Registration Number: NCT01829672
• Lead Sponsor: Medical University of Graz

Brief Summary

The aim of the study is to determine relevant hemodynamic parameters for the diagnostics of pulmonary arterial hypertension (PAH) by dynamic contrast enhanced dual-energy CT (DE-CT). In this prospective study the investigators validate DE-CT results of patients against hemodynamic parameters from right heart catheterisation and control the results by other clinical investigations. The investigators expect that using this non-invasive method, parameters relevant for the diagnosis of the patients with PAH, like pulmonary blood volume, blood flow and perfusion heterogeneity, can be determined.

Detailed Description

Pulmonary arterial hypertension (PAH) is a rare, life-threatening disease. It is characterized by the elevation of pulmonary arterial pressure and pulmonary vascular resistance. A remodeling of small pulmonary vessels characterized by the proliferation of the adventitia, the hypertrophy of the media and fibrosis of the intima can be observed on the microscopic level.

Non-invasive techniques for hemodynamic assessment and identification of early pulmonary vascular remodeling and pulmonary hypertension have a marked practical advantage as compared to invasive right heart catheterization, however, their accuracy and reliability is not well established.

In the present study the investigators examine patients who are scheduled for a thorax CT with an additional dynamic contrast-enhanced DE-CT protocol and derive established parameters for the diagnosis of PAH as well as novel parameters from the CT scans. These are compared to results from the right-heart catheterization and other investigations routinely carried out on these patients.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-11
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-07
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• patients with right heart catheterization data

Exclusion Criteria

• patients with decreased renal function
• patients who received CT in the previous six months
• intolerance of contrast material
• other standard CT contraindications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Other: pulmonary vascular disease	Dual-energy computed tomography investigation	Dual-energy computed tomography investigation

Primary Outcome Measures

Name	Time	Method
Pulmonary blood flow and volume determined by dual energy computed tomography	measurements with right heart catheterisation within 1 month	validation of pulmonary blood flow and volume of pulmonary hypertension patients

Secondary Outcome Measures

Name	Time	Method
Comparison of dual energy computed tomography derived data with clinical findings of pulmonary hypertension patients	measurements with right heart catheterisation within 1 month	comparison of different state or type of pulmonary hypertension
Lung perfusion heterogeneity determined by dual energy computed tomography	measurements with right heart catheterisation within 1 month	quantification of regional perfusion differences in pulmonary hypertension patients

Trial Locations

Locations (1)

Medical University Graz, Division of Pulmonology; 🇦🇹 Graz, Styria, Austria