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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Medical University of Graz
Sponsor:
Collaborator:
Ludwig Boltzmann Gesellschaft
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01829672
First received: April 9, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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 Intervention
Pulmonary Arterial Hypertension
Radiation: Dual-energy computed tomography investigation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography - Prospective Study

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Pulmonary blood flow and volume determined by dual energy computed tomography [ Time Frame: measurements with right heart catheterisation within 1 month ] [ Designated as safety issue: No ]
    validation of 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 [ Time Frame: measurements with right heart catheterisation within 1 month ] [ Designated as safety issue: No ]
    comparison of different state or type of pulmonary hypertension

  • Lung perfusion heterogeneity determined by dual energy computed tomography [ Time Frame: measurements with right heart catheterisation within 1 month ] [ Designated as safety issue: No ]
    quantification of regional perfusion differences in pulmonary hypertension patients


Estimated Enrollment: 55
Study Start Date: March 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829672

Locations
Austria
Medical University Graz, Division of Pulmonology Recruiting
Graz, Styria, Austria, 8010
Contact: Horst Olschewski, MD    +43-316-385-12183    horst.olschewski@medunigraz.at   
Contact: Michael Pienn, DI    +43-316-385-72899    michael.pienn@lvr.lbg.ac.at   
Principal Investigator: Horst Olschewski, MD         
Sponsors and Collaborators
Medical University of Graz
Ludwig Boltzmann Gesellschaft
Investigators
Principal Investigator: Horst Olschewski, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01829672     History of Changes
Other Study ID Numbers: 25-174 ex 12/13
Study First Received: April 9, 2013
Last Updated: February 18, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Graz:
Early diagnosis of pulmonary arterial hypertension
dynamic dual-energy computed tomography

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014