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Completed

NCT Number: NCT01607489

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Graz, Division of Pulmonology

Graz, Styria, 8010, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual-energy computed tomography investigation

Radiation

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

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

Other names: CT

Primary outcomes

  1. Pulmonary blood flow and volume determined by dual energy computed tomography

    Time frame: measurements with right heart catheterisation within 1 month

    determination of differences in pulmonary blood flow and volume of pulmonary hypertension patients

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Ludwig Boltzmann Gesellschaft

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
May 30, 2012
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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