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

NCT ID: NCT01829672

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-03-31

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Other: pulmonary vascular disease

Dual-energy computed tomography investigation

Group Type: EXPERIMENTAL

Dual-energy computed tomography investigation

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

Other Intervention Names

CT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ludwig Boltzmann Gesellschaft

OTHER

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Horst Olschewski, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University Graz, Division of Pulmonology

Graz, Styria, Austria

Countries

Austria

Other Identifiers

25-174 ex 12/13

Identifier Type: -

Identifier Source: org_study_id