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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Medical University of Graz
Sponsor:
Collaborator:
Ludwig Boltzmann Gesellschaft
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01829672
First received: April 9, 2013
Last updated: February 18, 2014
Last verified: February 2014

April 9, 2013
February 18, 2014
March 2013
March 2016   (final data collection date for primary outcome measure)
Pulmonary blood flow and volume determined by dual energy computed tomography [ Time Frame: measurements with right heart catheterisation within 1 month ] [ Designated as safety issue: No ]
validation of pulmonary blood flow and volume of pulmonary hypertension patients
Same as current
Complete list of historical versions of study NCT01829672 on ClinicalTrials.gov Archive Site
  • Comparison of dual energy computed tomography derived data with clinical findings of pulmonary hypertension patients [ Time Frame: measurements with right heart catheterisation within 1 month ] [ Designated as safety issue: No ]
    comparison of different state or type of pulmonary hypertension
  • Lung perfusion heterogeneity determined by dual energy computed tomography [ Time Frame: measurements with right heart catheterisation within 1 month ] [ Designated as safety issue: No ]
    quantification of regional perfusion differences in pulmonary hypertension patients
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Pulmonary Arterial Hypertension
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 Name: CT
Experimental: Other: pulmonary vascular disease
Dual-energy computed tomography investigation
Intervention: Radiation: Dual-energy computed tomography investigation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
55
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Austria
 
NCT01829672
25-174 ex 12/13
No
Medical University of Graz
Medical University of Graz
Ludwig Boltzmann Gesellschaft
Principal Investigator: Horst Olschewski, MD Medical University of Graz
Medical University of Graz
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP