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

Status

Completed

Intervention / Treatment

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

    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center

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
Pulmonary Hypertension
Patients having a right heart catheterization and CT pulmonary angiogram with a diagnosis of Pulmonary Hypertension
This study does not include an intervention but is observational in nature.
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
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
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.

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

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.

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