- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01135706
Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension
October 31, 2012 updated by: Karen Wood, Ohio State University
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
6
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients having a right heart catheterization and CT pulmonary angiogram
Description
Inclusion Criteria:
- Patients having a right heart catheterization and CT pulmonary angiogram
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Pulmonary Hypertension
Patients having a right heart catheterization and CT pulmonary angiogram with a diagnosis of Pulmonary Hypertension
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This study does not include an intervention but is observational in nature.
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Non Pulmonary Hypertension
Patients having a right heart catheterization and CT pulmonary angiogram without a diagnosis of Pulmonary Hypertension.
|
This study does not include an intervention but is observational in nature.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
FD of the pulmonary artery in patients with PH will be lower when compared to patients without PH.
Time Frame: 24 Months
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24 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
FD will correlate with the degree of PH as quantified by the MPAP obtained during RHC.
Time Frame: 24 Months
|
24 Months
|
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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
|
24 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen Wood, M.D., Ohio State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
May 20, 2010
First Submitted That Met QC Criteria
June 2, 2010
First Posted (Estimate)
June 3, 2010
Study Record Updates
Last Update Posted (Estimate)
November 1, 2012
Last Update Submitted That Met QC Criteria
October 31, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010H0097
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.