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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography - Prospective Study

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Radiation: Dual-energy computed tomography investigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Other: pulmonary vascular disease<br>Dual-energy computed tomography investigation | Radiation: Dual-energy computed tomography investigation<br>* 1x 20ml Ultravist (370mg J/ml)3-5ml/s, i.v. 1x 40ml Ultravist (370mg J/ml)3-5ml/s i.v. Contrast agent administration<br>* Other names: CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary blood flow and volume determined by dual energy computed tomography | validation of pulmonary blood flow and volume of pulmonary hypertension patients | measurements with right heart catheterisation within 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early diagnosis of pulmonary arterial hypertension, dynamic dual-energy computed tomography