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NCT02028299 Clinical Trial

Estimation of Pulmonary Vascular Resistance by Contrast Echocardiography

Pulmonary Arterial Hypertension Clinical Trial

Official title:
Estimation of Pulmonary Vascular Resistance by Contrast Echocardiography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02028299
Other study ID # 060922
Secondary ID
Status Completed
Phase N/A
First received August 20, 2013
Last updated January 3, 2014
Start date April 2010
Est. completion date July 2012

Study information
Verified date April 2013
Source George Washington University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

An echocardiogram using Definity contrast can provide the same information as the standard right heart catheterization.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients scheduled to undergo right heart catheterization at the George Washington University Hospital

Exclusion Criteria:

- Patients with known or suspected right-to-left bi-directional or transient right-to-left shunts or pulmonary arteriovenous malformations, previously documented moderate to severe tricuspid regurgitation or moderate to severe pulmonary regurgitation, evidence of right ventricular hypokinesis, or prior adverse reaction to Definity or hypersensitivity to perflutren

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• 2D doppler echo with Definity solution
Correlate right heart catheterization results with results from 2D doppler echo with Definity Solution

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
George Washington University

Outcome
Type Measure Description Time frame Safety issue
Primary Measure Pulmonary Vascular Resistance using 2D Doppler Echocardiogram w/Definity Solution Correlation coefficients between the technique above the the gold standard right heart catheterization measures of pulmonary vascular resistance. Two Years No
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