Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).

Phase 4

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Dextrose

• Registration Number: NCT00878878
• Lead Sponsor: GE Healthcare

Brief Summary

The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization for clinical reasons.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-08
• Study First Submitted QC: 2009-04-08
• Study First Posted: 2009-04-09
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2012-04-04
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-19
• Last Update Submitted: 2012-07-19
• Results First Posted: 2012-08-24
• Last Update Posted: 2012-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Must be already scheduled for left and/or right heart catheterization for clinical reasons.
• Must be in sinus rhythm, without an arrhythmia likely to affect the ability to assess pulmonary hemodynamics by catheterization, as determined by the investigator.
• Women of childbearing potential must be using adequate birth control and have a negative pregnancy test.

Exclusion Criteria

• History of right-to-left, bi-directional, or transient right-to-left cardiac shunts or diagnosed by color flow Doppler echocardiography during screening.
• Hypersensitivity to Optison, perflutren, blood, blood products, or albumin.
• Female subjects who are nursing mothers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm B	Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)	-
Arm A	Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)	-
Arm A	Dextrose	-
Arm B	Dextrose	-

Primary Outcome Measures

Name	Time	Method
Observed the Change of Pulmonary Artery Systolic Pressure (PASP) Measured by Millimeters of Mercury (mm hg) Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.	Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration	Measurement of the Pulmonary artery systolic pressure (PASP) results, which were taken from the subject in millimeters of mercury; a unit of pressure (mm hg), at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.
Observed the Change of Pulmonary Vascular Resistance (PVR) Measured by Wood Units Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.	Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration	Measurement of the pulmonary vascular resistance (PVR) results, which was taken from the subject in Wood Units, taken at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.

Secondary Outcome Measures

Name	Time	Method
Recorded Any Adverse Events From the Optison and Control Solution (5% Dextrose) Used in Subjects With Normal and Elevated Pulmonary Artery Systolic Pressure (PASP. This is Per Sequence and Not a Cross-over Study.	During the injection and catheterization procedure, and for up to 24 hours post-injection	Observe subjects with normal pulmonary artery systolic pressure (PASP) and elevated pulmonary artery systolic pressure (PASP) as measured by any adverse events.; The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; 11 subjects that were Normal PASP and 19 subjects that were Elevated PASP.; This is per sequence and not a cross-over study.

Trial Locations

Locations (1)

ICON Development Solutions; 🇺🇸 Elliott City, Maryland, United States