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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Radiation: Dual-energy computed tomography investigation

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Medical University Graz, Division of Pulmonology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Other: pulmonary vascular disease; Dual-energy computed tomography investigation	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; Other Names: CT

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Ludwig Boltzmann Gesellschaft

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: April 9, 2013
• First Submitted That Met QC Criteria: April 10, 2013
• First Posted (Estimate): April 11, 2013

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 7, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Early diagnosis of pulmonary arterial hypertension; dynamic dual-energy computed tomography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 25-174 ex 12/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO