Trial Outcomes & Findings for Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR). (NCT NCT00878878)
NCT ID: NCT00878878
Last Updated: 2012-08-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
Results posted on
2012-08-24
Participant Flow
Participant milestones
| Measure |
Optison First, Then Followed by Placebo Control
Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
|
Placebo Control First, Then Followed by Optison Product
Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).
Baseline characteristics by cohort
| Measure |
Optison First, Then Followed by Placebo Control
n=15 Participants
Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
|
Placebo Control First, Then Followed by Optison Product
n=15 Participants
Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age Continuous
|
53 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
60 years
STANDARD_DEVIATION 16.7 • n=7 Participants
|
57 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administrationPopulation: The Pulmonary artery systolic pressure (PASP) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.
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.
Outcome measures
| Measure |
Optison Given First, Then Placebo Control (5%Dextrose)
n=15 Participants
Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
|
Placebo Control (5% Dextrose) Given First, Then Optison
n=15 Participants
Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
|
|---|---|---|
|
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.
PASP (Units: mmHg) - Baseline
|
55.2 mm Hg
Standard Deviation 28.1
|
53.7 mm Hg
Standard Deviation 27.1
|
|
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.
2 min Post
|
55.6 mm Hg
Standard Deviation 27.9
|
53.8 mm Hg
Standard Deviation 26.9
|
|
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.
6 min Post
|
54.1 mm Hg
Standard Deviation 28.1
|
54.6 mm Hg
Standard Deviation 27.7
|
|
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.
10 min Post
|
54.57 mm Hg
Standard Deviation 27.0
|
54.9 mm Hg
Standard Deviation 27.6
|
PRIMARY outcome
Timeframe: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administrationPopulation: The pulmonary vascular resistance (PVR) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.
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.
Outcome measures
| Measure |
Optison Given First, Then Placebo Control (5%Dextrose)
n=15 Participants
Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
|
Placebo Control (5% Dextrose) Given First, Then Optison
n=15 Participants
Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
|
|---|---|---|
|
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.
10 min Post
|
3.8 Wood Units
Standard Deviation 3.4
|
3.5 Wood Units
Standard Deviation 3.3
|
|
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.
PVR (Units: Wood Units) - Baseline
|
3.6 Wood Units
Standard Deviation 2.9
|
3.9 Wood Units
Standard Deviation 4.0
|
|
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.
2 min Post
|
3.67 Wood Units
Standard Deviation 3.56
|
3.9 Wood Units
Standard Deviation 4.4
|
|
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.
6 min Post
|
3.3 Wood Units
Standard Deviation 2.9
|
3.87 Wood Units
Standard Deviation 3.68
|
SECONDARY outcome
Timeframe: During the injection and catheterization procedure, and for up to 24 hours post-injectionPopulation: The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; Normal PASP and Elevated PASP.
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.
Outcome measures
| Measure |
Optison Given First, Then Placebo Control (5%Dextrose)
n=11 Participants
Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
|
Placebo Control (5% Dextrose) Given First, Then Optison
n=19 Participants
Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
|
|---|---|---|
|
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.
Subjects with adverse event-up to 24h post
|
0 Adverse Events
|
1 Adverse Events
|
|
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.
Subjects with Serious adverse event up to 24h post
|
0 Adverse Events
|
0 Adverse Events
|
Adverse Events
Optison Product First Followed by Placebo Control (5%Dextrose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Control (5% Dextrose) First Followed by the Optison
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Optison Product First Followed by Placebo Control (5%Dextrose)
n=15 participants at risk
Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
|
Placebo Control (5% Dextrose) First Followed by the Optison
n=15 participants at risk
Placebo Control (5% Dextrose) given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP. There was a 15 minute interval between the injections.
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|---|---|---|
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Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place