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NCT01829672 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01829672
Other study ID # 25-174 ex 12/13
Secondary ID
Status Completed
Phase N/A
First received April 9, 2013
Last updated July 7, 2017
Start date March 2013
Est. completion date March 2017

Study information
Verified date July 2017
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Radiation:
• Dual-energy computed tomography investigation
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

Locations
Country Name City State
Austria Medical University Graz, Division of Pulmonology Graz Styria

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Graz Ludwig Boltzmann Gesellschaft

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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