Pulmonary Arterial HypertensionNCT01829672
Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography
A study testing Dual-energy computed tomography investigation in people with Pulmonary Arterial Hypertension, run by Medical University of Graz at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Dual-energy computed tomography investigation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2013to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with right heart catheterization data
Who cannot join
- patients with decreased renal function
- patients who received CT in the previous six months
- intolerance of contrast material
- other standard CT contraindications
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Graz, Division of Pulmonology
Graz, Styria, 8010
About this study
Official title: Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography - Prospective Study
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.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Dual-energy computed tomography investigation
- Keywords
- Early diagnosis of pulmonary arterial hypertension, dynamic dual-energy computed tomography
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-energy computed tomography investigationRadiation
Also called CT
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
| Study group | Role | What they receive |
|---|---|---|
| Other: pulmonary vascular disease | Experimental | Dual-energy computed tomography investigation Receives: Radiation: Dual-energy computed tomography investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary blood flow and volume determined by dual energy computed tomography
validation of pulmonary blood flow and volume of pulmonary hypertension patients
Measured: 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
comparison of different state or type of pulmonary hypertension
Measured: measurements with right heart catheterisation within 1 month
Lung perfusion heterogeneity determined by dual energy computed tomography
quantification of regional perfusion differences in pulmonary hypertension patients
Measured: measurements with right heart catheterisation within 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Boltzmann Gesellschaft
- Responsible party
- Sponsor
- Investigators
- Horst Olschewski, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829672
- Sponsor's protocol ID
- 25-174 ex 12/13
- Status last verified
- Jul 2017
- First submitted
- 9 Apr 2013
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography - Prospective Study
- ClinicalTrials.gov ID
- NCT01829672
- Acronym / sponsor ID
- 25-174 ex 12/13
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Early diagnosis of pulmonary arterial hypertension, dynamic dual-energy computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Ludwig Boltzmann Gesellschaft
- Study start
- Mar 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Other: pulmonary vascular disease | Experimental | Radiation: Dual-energy computed tomography investigationDual-energy computed tomography investigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with right heart catheterization data
Key exclusion criteria (4 listed)
- patients with decreased renal function
- patients who received CT in the previous six months
- intolerance of contrast material
- other standard CT contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-energy computed tomography investigationAlso: CT1x 20ml Ultravist (370mg J/ml)3-5ml/s, i.v. 1x 40ml Ultravist (370mg J/ml)3-5ml/s i.v. Contrast agent administration | Radiation | Other: pulmonary vascular disease |
Primary outcome
Pulmonary blood flow and volume determined by dual energy computed tomography
Time frame: measurements with right heart catheterisation within 1 month
validation of pulmonary blood flow and volume of pulmonary hypertension patients
2 secondary outcomes
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
Lung perfusion heterogeneity determined by dual energy computed tomography
Time frame: measurements with right heart catheterisation within 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horst Olschewski, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-energy computed tomography investigation in people with Pulmonary Arterial Hypertension, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary blood flow and volume determined by dual energy computed tomography (time frame: measurements with right heart catheterisation within 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.