NCT01135706

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

May 20, 2010

Last Update Submit

October 31, 2012

Conditions

Pulmonary Hypertension

Keywords

Pulmonary HypertensionFractal dimension

Outcome Measures

Primary Outcomes (1)

  • FD of the pulmonary artery in patients with PH will be lower when compared to patients without PH.

    24 Months

Secondary Outcomes (2)

  • FD will correlate with the degree of PH as quantified by the MPAP obtained during RHC.

    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.

    24 Months

Study Arms (2)

Pulmonary Hypertension

Patients having a right heart catheterization and CT pulmonary angiogram with a diagnosis of Pulmonary Hypertension

Other: No Intervention

Non Pulmonary Hypertension

Patients having a right heart catheterization and CT pulmonary angiogram without a diagnosis of Pulmonary Hypertension.

Other: No Intervention

Interventions

No InterventionOTHER

This study does not include an intervention but is observational in nature.

Non Pulmonary HypertensionPulmonary Hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having a right heart catheterization and CT pulmonary angiogram

You may qualify if:

  • Patients having a right heart catheterization and CT pulmonary angiogram

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Karen Wood, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 20, 2010

First Posted

June 3, 2010

Study Start

April 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

US(1)