Pulmonary HypertensionNCT01135706
Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension
An observational study of Pulmonary Hypertension, run by Ohio State University at 1 site in United States.
Trial summary
The investigators propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the FD correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Feb 2012
- Phase
- Observational
- 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
Study population: Patients having a right heart catheterization and CT pulmonary angiogram
Who may be able to join
- Patients having a right heart catheterization and CT pulmonary angiogram
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension.
The investigators propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the FD correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements.
Read the detailed description
Pulmonary hypertension (PH) is an insidious disorder that can occur in isolation or as a result of various other pulmonary and systemic conditions. If left untreated PH may progress to right heart failure and death. Numerous tests are suggestive but not diagnostic of PH including cardiac echo, pulmonary function testing and chest x-ray. Definitive diagnosis requires right heart catheterization that is invasive, costly and time consuming. The fractal dimension (FD) is an index of the space-filling properties of an object so that the closer the dimension is to the topological dimension in which the object is embedded, the greater the space filling properties. No investigations have been performed to analyze the fractal dimension of pulmonary arteries in patients with PH. We propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the FD correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements.
- Conditions
- Pulmonary Hypertension
- Being tested
- No Intervention
- Keywords
- Pulmonary Hypertension, Fractal dimension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This study does not include an intervention but is observational in nature.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Hypertension | Patients having a right heart catheterization and CT pulmonary angiogram with a diagnosis of Pulmonary Hypertension Receives: Other: No Intervention | |
| Non Pulmonary Hypertension | Patients having a right heart catheterization and CT pulmonary angiogram without a diagnosis of Pulmonary Hypertension. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
FD of the pulmonary artery in patients with PH will be lower when compared to patients without PH.
Measured: 24 Months
Secondary outcomes (2)
FD will correlate with the degree of PH as quantified by the MPAP obtained during RHC.
Measured: 24 Months
FD will correlate with the functional capacity of the PH patients as quantified by distance during six-minute walk and NYHA functional class.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Wood, Ohio State University
- Investigators
- Karen Wood, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135706
- Sponsor's protocol ID
- 2010H0097
- Status last verified
- Oct 2012
- First submitted
- 20 May 2010
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension.
- ClinicalTrials.gov ID
- NCT01135706
- Acronym / sponsor ID
- 2010H0097
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Fractal dimension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 Jun 2010 (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 investigators propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the FD correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements.
Detailed description
Pulmonary hypertension (PH) is an insidious disorder that can occur in isolation or as a result of various other pulmonary and systemic conditions. If left untreated PH may progress to right heart failure and death. Numerous tests are suggestive but not diagnostic of PH including cardiac echo, pulmonary function testing and chest x-ray. Definitive diagnosis requires right heart catheterization that is invasive, costly and time consuming. The fractal dimension (FD) is an index of the space-filling properties of an object so that the closer the dimension is to the topological dimension in which the object is embedded, the greater the space filling properties. No investigations have been performed to analyze the fractal dimension of pulmonary arteries in patients with PH. We propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the FD correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Hypertension | – | Other: No InterventionPatients having a right heart catheterization and CT pulmonary angiogram with a diagnosis of Pulmonary Hypertension |
| Non Pulmonary Hypertension | – | Other: No InterventionPatients having a right heart catheterization and CT pulmonary angiogram without a diagnosis of Pulmonary Hypertension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having a right heart catheterization and CT pulmonary angiogram
Key inclusion criteria (1 listed)
- Patients having a right heart catheterization and CT pulmonary angiogram
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No InterventionThis study does not include an intervention but is observational in nature. | Other | Non Pulmonary Hypertension, Pulmonary Hypertension |
Primary outcome
FD of the pulmonary artery in patients with PH will be lower when compared to patients without PH.
Time frame: 24 Months
2 secondary outcomes
FD will correlate with the degree of PH as quantified by the MPAP obtained during RHC.
Time frame: 24 Months
FD will correlate with the functional capacity of the PH patients as quantified by distance during six-minute walk and NYHA functional class.
Time frame: 24 Months
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 1 Nov 2012.
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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.
Karen Wood, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Ohio State University at 1 site in United States.
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 1 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 1 Nov 2012. 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 United States. 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?
FD of the pulmonary artery in patients with PH will be lower when compared to patients without PH. (time frame: 24 Months). 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 1 Nov 2012.