Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography
Primary Purpose
Pulmonary Arterial Hypertension
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Dual-energy computed tomography investigation
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Arterial Hypertension focused on measuring Early diagnosis of pulmonary arterial hypertension, dynamic dual-energy computed tomography
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
Sites / Locations
- Medical University Graz, Division of Pulmonology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
pulmonary vascular disease
Arm Description
Dual-energy computed tomography investigation
Outcomes
Primary Outcome Measures
Pulmonary blood flow and volume determined by dual energy computed tomography
determination of differences in pulmonary blood flow and volume of pulmonary hypertension patients
Secondary Outcome Measures
Comparison of dual energy computed tomography derived data with clinical findings of pulmonary hypertension patients
comparison of different state or type of pulmonary hypertension
Lung perfusion heterogeneity determined by dual energy computed tomography
quantification of regional perfusion differences in pulmonary hypertension patients
Full Information
NCT ID
NCT01607489
First Posted
April 13, 2012
Last Updated
July 12, 2017
Sponsor
Medical University of Graz
Collaborators
Ludwig Boltzmann Gesellschaft
1. Study Identification
Unique Protocol Identification Number
NCT01607489
Brief Title
Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography
Official Title
Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
Collaborators
Ludwig Boltzmann Gesellschaft
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Early diagnosis of pulmonary arterial hypertension, dynamic dual-energy computed tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pulmonary vascular disease
Arm Type
Other
Arm Description
Dual-energy computed tomography investigation
Intervention Type
Radiation
Intervention Name(s)
Dual-energy computed tomography investigation
Other Intervention Name(s)
CT
Intervention Description
1x 20ml Ultravist (370mg J/ml)3-5ml/s,
1x 70ml Ultravist (370mg J/ml)3-5ml/s Contrast agent administration
Primary Outcome Measure Information:
Title
Pulmonary blood flow and volume determined by dual energy computed tomography
Description
determination of differences in pulmonary blood flow and volume of pulmonary hypertension patients
Time Frame
measurements with right heart catheterisation within 1 month
Secondary Outcome Measure Information:
Title
Comparison of dual energy computed tomography derived data with clinical findings of pulmonary hypertension patients
Description
comparison of different state or type of pulmonary hypertension
Time Frame
measurements with right heart catheterisation within 1 month
Title
Lung perfusion heterogeneity determined by dual energy computed tomography
Description
quantification of regional perfusion differences in pulmonary hypertension patients
Time Frame
measurements with right heart catheterisation within 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horst Olschewski, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Graz, Division of Pulmonology
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8010
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24498123
Citation
Helmberger M, Pienn M, Urschler M, Kullnig P, Stollberger R, Kovacs G, Olschewski A, Olschewski H, Balint Z. Quantification of tortuosity and fractal dimension of the lung vessels in pulmonary hypertension patients. PLoS One. 2014 Jan 31;9(1):e87515. doi: 10.1371/journal.pone.0087515. eCollection 2014.
Results Reference
result
PubMed Identifier
24311231
Citation
Pienn M, Kovacs G, Tscherner M, Avian A, Johnson TR, Kullnig P, Stollberger R, Olschewski A, Olschewski H, Balint Z. Non-invasive determination of pulmonary hypertension with dynamic contrast-enhanced computed tomography: a pilot study. Eur Radiol. 2014 Mar;24(3):668-76. doi: 10.1007/s00330-013-3067-8. Epub 2013 Dec 6.
Results Reference
result
PubMed Identifier
23974909
Citation
Pienn M, Kovacs G, Tscherner M, Johnson TR, Kullnig P, Stollberger R, Olschewski A, Olschewski H, Balint Z. Determination of cardiac output with dynamic contrast-enhanced computed tomography. Int J Cardiovasc Imaging. 2013 Dec;29(8):1871-8. doi: 10.1007/s10554-013-0279-6. Epub 2013 Aug 23.
Results Reference
result
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Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography
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