A Phase 4 interventional study of Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) and Dextrose in Pulmonary Hypertension, sponsored by GE Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-24.
Sponsored by GE Healthcare · Phase 4, Interventional, and Diagnostic
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 30 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →GE Healthcare is the lead sponsor of 168 studies on the registry; 19 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
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Exclusion Criteria:
Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) · Drug: Dextrose
Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) · Drug: Dextrose
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.
Also known as: Perflutren Protein-Type A Microspheres Injectable Suspension
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.
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.
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.
Time frame: 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.
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.
Time frame: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
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.
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.
Time frame: During the injection and catheterization procedure, and for up to 24 hours post-injection
| Milestone | Optison First, Then Followed by Placebo Control | Placebo Control First, Then Followed by Optison Product |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
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.
| mm Hg | Optison Given First, Then Placebo Control (5%Dextrose) | Placebo Control (5% Dextrose) Given First, Then Optison |
|---|---|---|
| PASP (Units: mmHg) - Baseline | 55.2 ± 28.1 | 53.7 ± 27.1 |
| 2 min Post | 55.6 ± 27.9 | 53.8 ± 26.9 |
| 6 min Post | 54.1 ± 28.1 | 54.6 ± 27.7 |
| 10 min Post | 54.57 ± 27.0 | 54.9 ± 27.6 |
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.
| Adverse Events | Normal Pulmonary Artery Systolic Pressure (PASP) | Elevated Pulmonary Artery Systolic Pressure (PASP) |
|---|---|---|
| Subjects with Serious adverse event up to 24h post | 0 | 0 |
| Subjects with adverse event-up to 24h post | 0 | 1 |
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.
| Wood Units | Optison Given First, Then Placebo Control (5%Dextrose) | Placebo Control (5% Dextrose) Given First, Then Optison |
|---|---|---|
| PVR (Units: Wood Units) - Baseline | 3.6 ± 2.9 | 3.9 ± 4.0 |
| 2 min Post | 3.67 ± 3.56 | 3.9 ± 4.4 |
| 6 min Post | 3.3 ± 2.9 | 3.87 ± 3.68 |
| 10 min Post | 3.8 ± 3.4 | 3.5 ± 3.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Optison Product First Followed by Placebo Control (5%Dextrose) | — | 0/15 (0%) | 0/15 (0%) |
| Placebo Control (5% Dextrose) First Followed by the Optison | — | 0/15 (0%) | 1/15 (6.7%) |
| Event | Optison Product First Followed by Placebo Control (5%Dextrose) | Placebo Control (5% Dextrose) First Followed by the Optison |
|---|---|---|
| Procedural PainInjury, poisoning and procedural complications | 0/15 | 1/15 |
| Age, Categorical(Participants) | Optison First, Then Followed by Placebo Control | Placebo Control First, Then Followed by Optison Product | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 8 | 17 |
| >=65 years | 6 | 7 | 13 |
| Age Continuous(years) | Optison First, Then Followed by Placebo Control | Placebo Control First, Then Followed by Optison Product | Total |
|---|---|---|---|
| Mean | 53 ± 16.1 | 60 ± 16.7 | 57 ± 16.5 |
| Sex: Female, Male(Participants) | Optison First, Then Followed by Placebo Control | Placebo Control First, Then Followed by Optison Product | Total |
|---|---|---|---|
| Female | 7 | 9 | 16 |
| Male | 8 | 6 | 14 |
| Region of Enrollment(participants) | Optison First, Then Followed by Placebo Control | Placebo Control First, Then Followed by Optison Product | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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