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

NCT ID: NCT01607489

Last Updated: 2017-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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pulmonary vascular disease

Dual-energy computed tomography investigation

Group Type OTHER

Dual-energy computed tomography investigation

Intervention Type RADIATION

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

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

Interventions

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Dual-energy computed tomography investigation

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

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

Intervention Type RADIATION

Other Intervention Names

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CT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig Boltzmann Gesellschaft

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Horst Olschewski, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University Graz, Division of Pulmonology

Graz, Styria, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type RESULT
PMID: 24498123 (View on PubMed)

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.

Reference Type RESULT
PMID: 24311231 (View on PubMed)

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.

Reference Type RESULT
PMID: 23974909 (View on PubMed)

Other Identifiers

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23-356 ex 10/11

Identifier Type: -

Identifier Source: org_study_id

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