Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).
A Phase 4, Placebo Controlled, Single-blind, Cross-over Safety Study to Evaluate the Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR) as Measured by Right Heart Catheterization
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Maryland
-
Elliott City, Maryland, United States, 21043
- ICON Development Solutions
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm A
|
Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose. Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.
Other Names:
Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose. Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison. |
|
Experimental: Arm B
|
Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose. Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.
Other Names:
Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose. Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: 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.
|
Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
|
|
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.
Time Frame: 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.
|
Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: 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. |
During the injection and catheterization procedure, and for up to 24 hours post-injection
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Christopher Jefferds, ICON Development Solutions
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GE-191-004
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