Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135706
• Other study ID #: 2010H0097
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: October 31, 2012
• Start date: April 2010
• Est. completion date: February 2012

Study information

• Verified date: October 2012
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients having a right heart catheterization and CT pulmonary angiogram

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Other:
• No Intervention
This study does not include an intervention but is observational in nature.

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FD of the pulmonary artery in patients with PH will be lower when compared to patients without PH.		24 Months	No
Secondary	FD will correlate with the degree of PH as quantified by the MPAP obtained during RHC.		24 Months	No
Secondary	FD will correlate with the functional capacity of the PH patients as quantified by distance during six-minute walk and NYHA functional class.		24 Months	No