Trial · NCT00878878
Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).
NCT00878878, Phase 4, Completed, GE Healthcare; results first posted 2012-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR). Trials, record NCT00878878. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00878878
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).
- NCT number
- NCT00878878
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 30 participants, actual
- Lead sponsor
- GE Healthcare
- Conditions
- Pulmonary Hypertension
- Interventions
- Optison (Perflutren Protein-Type A Microspheres Injectable Suspension), Dextrose
- First posted
- 2009-04-09
- Last updated
- 2012-08-24
- Results first posted
- 2012-08-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | 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. |
| 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. | 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 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration | The Pulmonary artery systolic pressure (PASP) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes. | mm Hg | MEAN |
| 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. | During the injection and catheterization procedure, and for up to 24 hours post-injection | The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; Normal PASP and Elevated PASP. | Adverse Events | NUMBER |
| 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. | Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration | The pulmonary vascular resistance (PVR) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes. | Wood Units | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Optison Given First, Then Placebo Control (5%Dextrose) | PASP (Units: mmHg) - Baseline | 55.2 | Standard Deviation 28.1 | mm Hg |
| 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. | Placebo Control (5% Dextrose) Given First, Then Optison | PASP (Units: mmHg) - Baseline | 53.7 | Standard Deviation 27.1 | mm Hg |
| 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. | Optison Given First, Then Placebo Control (5%Dextrose) | 2 min Post | 55.6 | Standard Deviation 27.9 | mm Hg |
| 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. | Placebo Control (5% Dextrose) Given First, Then Optison | 2 min Post | 53.8 | Standard Deviation 26.9 | mm Hg |
| 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. | Optison Given First, Then Placebo Control (5%Dextrose) | 6 min Post | 54.1 | Standard Deviation 28.1 | mm Hg |
| 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. | Placebo Control (5% Dextrose) Given First, Then Optison | 6 min Post | 54.6 | Standard Deviation 27.7 | mm Hg |
| 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. | Optison Given First, Then Placebo Control (5%Dextrose) | 10 min Post | 54.57 | Standard Deviation 27.0 | mm Hg |
| 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. | Placebo Control (5% Dextrose) Given First, Then Optison | 10 min Post | 54.9 | Standard Deviation 27.6 | mm Hg |
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. | Normal Pulmonary Artery Systolic Pressure (PASP) | Subjects with Serious adverse event up to 24h post | 0 | 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. | Elevated Pulmonary Artery Systolic Pressure (PASP) | Subjects with Serious adverse event up to 24h post | 0 | Adverse Events |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Optison First, Then Followed by Placebo Control | 15 | |
| Overall Study | STARTED | Placebo Control First, Then Followed by Optison Product | 15 | |
| Overall Study | COMPLETED | Optison First, Then Followed by Placebo Control | 15 | |
| Overall Study | COMPLETED | Placebo Control First, Then Followed by Optison Product | 15 | |
| Overall Study | NOT COMPLETED | Optison First, Then Followed by Placebo Control | 0 | |
| Overall Study | NOT COMPLETED | Placebo Control First, Then Followed by Optison Product | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Procedural Pain | Injury, poisoning and procedural complications | Optison Product First Followed by Placebo Control (5%Dextrose) | 0 | 15 | 0 |
| other | Procedural Pain | Injury, poisoning and procedural complications | Placebo Control (5% Dextrose) First Followed by the Optison | 1 | 15 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Optison Product First Followed by Placebo Control (5%Dextrose) | ||
| Total, all-cause mortality | Placebo Control (5% Dextrose) First Followed by the Optison | ||
| Total, other adverse events | Optison Product First Followed by Placebo Control (5%Dextrose) | 0 | 15 |
| Total, other adverse events | Placebo Control (5% Dextrose) First Followed by the Optison | 1 | 15 |
| Total, serious adverse events | Optison Product First Followed by Placebo Control (5%Dextrose) | 0 | 15 |
| Total, serious adverse events | Placebo Control (5% Dextrose) First Followed by the Optison | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Optison Product First Followed by Placebo Control (5%Dextrose) vs Placebo Control (5% Dextrose) First Followed by the Optison: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00878878
GET https://conductscience.org/api/trials/v1/NCT00878878/registered