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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) | Drug | 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. |
| 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. | 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. | 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 |
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Jefferds | ICON Development Solutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Development Solutions | Elliott | Maryland | 21043 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo Control First, Then Followed by Optison Product |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | The Pulmonary artery systolic pressure (PASP) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes. | Posted | Mean | Standard Deviation | mm Hg | Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Optison Product First Followed by Placebo Control (5%Dextrose) | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruben Sheng, M.D. | GE Healthcare | 1-609-514-6899 | Rubin.Sheng@ge.com |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C099458 | FS 069 |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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|
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| Dextrose | Drug | 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. |
|
| During the injection and catheterization procedure, and for up to 24 hours post-injection |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo Control (5% Dextrose) Given First, Then Optison | 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. |
|
|
| 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. | 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. | The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; Normal PASP and Elevated PASP. | Posted | Number | Adverse Events | During the injection and catheterization procedure, and for up to 24 hours post-injection |
|
|
|
| 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. | 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. | The pulmonary vascular resistance (PVR) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes. | Posted | Mean | Standard Deviation | Wood Units | Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo Control (5% Dextrose) First Followed by the Optison | 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. | 0 | 15 | 1 | 15 |
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| D002318 |
| Cardiovascular Diseases |
| 6 min Post |
|
| 10 min Post |
|