Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Wood, Ohio State University
ClinicalTrials.gov Identifier:
NCT01135706
First received: May 20, 2010
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Pulmonary Hypertension
Other: No Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension.

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • FD of the pulmonary artery in patients with PH will be lower when compared to patients without PH. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FD will correlate with the degree of PH as quantified by the MPAP obtained during RHC. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: April 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pulmonary Hypertension
Patients having a right heart catheterization and CT pulmonary angiogram with a diagnosis of Pulmonary Hypertension
Other: No Intervention
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.
Other: No Intervention
This study does not include an intervention but is observational in nature.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients having a right heart catheterization and CT pulmonary angiogram

Criteria

Inclusion Criteria:

  • Patients having a right heart catheterization and CT pulmonary angiogram

Exclusion Criteria:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01135706

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Karen Wood, M.D. Ohio State University
  More Information

No publications provided

Responsible Party: Karen Wood, M.D., Ohio State University
ClinicalTrials.gov Identifier: NCT01135706     History of Changes
Other Study ID Numbers: 2010H0097
Study First Received: May 20, 2010
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Pulmonary Hypertension
Fractal dimension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014