Phase 4
N=30
Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).
Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00878878 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: 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. — 55.2; 53.7; 55.6; 53.8 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) (Drug); Dextrose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
55.2; 53.7; 55.6; 53.8; 54.1; 54.6 | — |
| PRIMARY 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. |
3.6; 3.9; 3.67; 3.9; 3.3; 3.87 | — |
| SECONDARY 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. |
0; 0; 0; 1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00878878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.