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

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ClinicalTrials.gov Identifier: NCT01829672
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Ludwig Boltzmann Gesellschaft
Information provided by (Responsible Party):
Medical University of Graz

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Radiation: Dual-energy computed tomography investigation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography - Prospective Study
Study Start Date : March 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

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Arms and Interventions
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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 Name: CT


Outcome Measures
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Primary Outcome Measures :
  1. Pulmonary blood flow and volume determined by dual energy computed tomography [ Time Frame: measurements with right heart catheterisation within 1 month ]
    validation of pulmonary blood flow and volume of pulmonary hypertension patients


Secondary Outcome Measures :
  1. 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 ]
    comparison of different state or type of pulmonary hypertension

  2. Lung perfusion heterogeneity determined by dual energy computed tomography [ Time Frame: measurements with right heart catheterisation within 1 month ]
    quantification of regional perfusion differences in pulmonary hypertension patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829672


Locations
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Austria
Medical University Graz, Division of Pulmonology
Graz, Styria, Austria, 8010
Sponsors and Collaborators
Medical University of Graz
Ludwig Boltzmann Gesellschaft
Investigators
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Principal Investigator: Horst Olschewski, MD Medical University of Graz
More Information
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01829672    
Other Study ID Numbers: 25-174 ex 12/13
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medical University of Graz:
Early diagnosis of pulmonary arterial hypertension
dynamic dual-energy computed tomography
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases