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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ludwig Boltzmann Gesellschaft
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01607489
First received: April 13, 2012
Last updated: April 9, 2013
Last verified: April 2013
History of Changes

April 13, 2012
April 9, 2013
June 2011
May 2013   (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 ]
determination of differences in pulmonary blood flow and volume of pulmonary hypertension patients
  • Pulmonary blood volume determined by dual energy computed tomography [ Time Frame: measurements with right heart catheterisation within 1 month ] [ Designated as safety issue: No ]
    determination of differences in pulmonary blood volume of pulmonary hypertension patients
  • Pulmonary blood flow determined by dual energy computed tomography [ Time Frame: measurements with right heart catheterisation within 1 month ] [ Designated as safety issue: No ]
    quantitative evaluation of blood flow in patients with 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
Complete list of historical versions of study NCT01607489 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
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
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 - Pilot 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 pilot study the investigators investigate patients who underwent right heart catheterisation with DE-CT to determine hemodynamic parameters 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 underwent right heart catheterization and 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,

1x 70ml Ultravist (370mg J/ml)3-5ml/s Contrast agent administration

Other Name: CT
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.
 
Active, not recruiting
25
October 2013
May 2013   (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
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01607489
23-356 ex 10/11
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
April 2013

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