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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01607489
Enrollment
25
Registered
2012-05-30
Start date
2011-06-30
Completion date
2017-03-31
Last updated
2017-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

Early diagnosis of pulmonary arterial hypertension, dynamic dual-energy computed tomography

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.

Interventions

1x 20ml Ultravist (370mg J/ml)3-5ml/s, 1x 70ml Ultravist (370mg J/ml)3-5ml/s Contrast agent administration

Sponsors

Ludwig Boltzmann Gesellschaft
CollaboratorOTHER
Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary blood flow and volume determined by dual energy computed tomographymeasurements with right heart catheterisation within 1 monthdetermination of differences in pulmonary blood flow and volume of pulmonary hypertension patients

Secondary

MeasureTime frameDescription
Comparison of dual energy computed tomography derived data with clinical findings of pulmonary hypertension patientsmeasurements with right heart catheterisation within 1 monthcomparison of different state or type of pulmonary hypertension
Lung perfusion heterogeneity determined by dual energy computed tomographymeasurements with right heart catheterisation within 1 monthquantification of regional perfusion differences in pulmonary hypertension patients

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026