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

NCT01829672 | Completed

• 1 other identifier: 25-174 ex 12/13
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Early diagnosis of pulmonary arterial hypertension; dynamic dual-energy computed tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of dual energy computed tomography derived data with clinical findings of pulmonary hypertension patients

  measurements with right heart catheterisation within 1 month

• Lung perfusion heterogeneity determined by dual energy computed tomography

  measurements with right heart catheterisation within 1 month

Study Arms (1)

Other: pulmonary vascular disease

EXPERIMENTAL

Dual-energy computed tomography investigation

Radiation: Dual-energy computed tomography investigation

Interventions

Dual-energy computed tomography investigation 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

Also known as: CT

Other: pulmonary vascular disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with right heart catheterization data

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead
• Ludwig Boltzmann Gesellschaft: collaborator

Study Sites (1)

Medical University Graz, Division of Pulmonology

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Horst Olschewski, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 11, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)