Pulmonary Hypertension
Conditions
Keywords
Pulmonary artery systolic pressure (PASP), Pulmonary Vascular Resistance (PVR), Right Heart Catheterization, Pulmonary hemodynamics
Brief 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.
Interventions
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.
DRUGDextrose
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.
Sponsors
ICON Clinical Research
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Placebo Control First, Then Followed by Optison Product | Optison First, Then Followed by Placebo Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 9 Participants | 17 Participants |
| Age Continuous | 60 years STANDARD_DEVIATION 16.7 | 53 years STANDARD_DEVIATION 16.1 | 57 years STANDARD_DEVIATION 16.5 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 16 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
Population: The Pulmonary artery systolic pressure (PASP) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Optison Given First, Then Placebo Control (5%Dextrose) | 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 |
| Optison Given First, Then Placebo Control (5%Dextrose) | 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 |
| Optison Given First, Then Placebo Control (5%Dextrose) | 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 |
| Optison Given First, Then Placebo Control (5%Dextrose) | 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 |
| Placebo Control (5% Dextrose) Given First, Then 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. | 10 min Post | 54.9 mm Hg | Standard Deviation 27.6 |
| Placebo Control (5% Dextrose) Given First, Then 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. | PASP (Units: mmHg) - Baseline | 53.7 mm Hg | Standard Deviation 27.1 |
| Placebo Control (5% Dextrose) Given First, Then 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. | 2 min Post | 53.8 mm Hg | Standard Deviation 26.9 |
| Placebo Control (5% Dextrose) Given First, Then 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. | 6 min Post | 54.6 mm Hg | Standard Deviation 27.7 |
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.
Time frame: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
Population: The pulmonary vascular resistance (PVR) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Optison Given First, Then Placebo Control (5%Dextrose) | 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 |
| Optison Given First, Then Placebo Control (5%Dextrose) | 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 |
| Optison Given First, Then Placebo Control (5%Dextrose) | 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 |
| Optison Given First, Then Placebo Control (5%Dextrose) | 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 |
| Placebo Control (5% Dextrose) Given First, Then Optison | 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 | 3.5 Wood Units | Standard Deviation 3.3 |
| Placebo Control (5% Dextrose) Given First, Then Optison | 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 | 3.9 Wood Units | Standard Deviation 4 |
| Placebo Control (5% Dextrose) Given First, Then Optison | 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 | 3.87 Wood Units | Standard Deviation 3.68 |
| Placebo Control (5% Dextrose) Given First, Then Optison | 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 | 3.9 Wood Units | Standard Deviation 4.4 |
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.
Time frame: During the injection and catheterization procedure, and for up to 24 hours post-injection
Population: The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; Normal PASP and Elevated PASP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Optison Given First, Then Placebo Control (5%Dextrose) | 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 |
| Optison Given First, Then Placebo Control (5%Dextrose) | 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 |
| Placebo Control (5% Dextrose) Given First, Then Optison | 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 |
| Placebo Control (5% Dextrose) Given First, Then Optison | 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 | 1 Adverse Events |