Clinical trial NCT01607489: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: Early diagnosis of pulmonary arterial hypertension
dynamic dual-energy computed tomography
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Ludwig Boltzmann Gesellschaft
First posted: 2012-05-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Pulmonary blood flow and volume determined by dual energy computed tomography
timeFrame: measurements with right heart catheterisation within 1 month
Secondary outcomes:
measure: Comparison of dual energy computed tomography derived data with clinical findings of pulmonary hypertension patients
timeFrame: measurements with right heart catheterisation within 1 month
measure: Lung perfusion heterogeneity determined by dual energy computed tomography
timeFrame: measurements with right heart catheterisation within 1 month
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz, Division of Pulmonology
state: Steiermark
Study officials:
affiliation: Medical University of Graz
name: Horst Olschewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.