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

NCT01607489 | Completed

• 1 other identifier: 23-356 ex 10/11
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pulmonary blood flow and volume determined by dual energy computed tomography

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

  measurements with right heart catheterisation within 1 month

Secondary Outcomes (2)

• Comparison of dual energy computed tomography derived data with clinical findings of pulmonary hypertension patients

  measurements with right heart catheterisation within 1 month

• Lung perfusion heterogeneity determined by dual energy computed tomography

  measurements with right heart catheterisation within 1 month

Study Arms (1)

pulmonary vascular disease

OTHER

Dual-energy computed tomography investigation

Radiation: Dual-energy computed tomography investigation

Interventions

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

Also known as: CT

pulmonary vascular disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with right heart catheterization data

You may not qualify if:

• patients with decreased renal function
• patients who received CT in the previous six months
• intolerance of contrast material
• other standard CT contraindications

Sponsors & Collaborators

• Medical University of Graz: lead
• Ludwig Boltzmann Gesellschaft: collaborator

Study Sites (1)

Medical University Graz, Division of Pulmonology

Graz, Styria, 8010, Austria

Location

Related Publications (3)

• 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.

  PMID: 24498123 RESULT

• 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.

  PMID: 24311231 RESULT

• 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.

  PMID: 23974909 RESULT

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Horst Olschewski, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: May 30, 2012
• Study Start: June 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)