Echocardiography
Conditions
Keywords
Surveillance, Optison, Perflutren, Echocardiography, Subjects receive Optison during enhanced echocardiography
Brief summary
This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.
Interventions
DRUGPerflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)
The recommended dose of Optison is 0.5mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed. The injection rate should not exceed 1mL per second. Follow the Optison injection with a flush of 0.9% sodium chloride injection, USP or 5% dextrose in water injection, United States Pharmacopeia (USP) . The maximum total dose should not exceed 5.0mL in any 10 minutes period. The maximum total dose should not exceed 8.7mL in any one patient study.
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is over 18 years old. * The subject has been scheduled for an Optison-enhanced echocardiography exam. * The subject has provided signed and dated informed consent.
Exclusion criteria
* Known hypersensitivity to perflutren, blood, blood products or albumin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice. | Within 24 hours post contrast administration | A Serious Adverse Reaction or (SAR) is considered causally related to the Optison product administered by the investigator. This reaction, should it occur, will be counted as a serious adverse reaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice. | Within 24 hours post contrast administration | The frequency of any serious adverse event (SAE) whether it is related to the Optison product or not, after the administration of the Optison product during contrast enhanced echocardiography. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - Optison Open Label with 1039 subjects that received Optison to evaluate the safety of the product | 1,039 |
| Total | 1,039 |
Baseline characteristics
| Characteristic | Arm 1 - Optison |
|---|---|
| Age Continuous | 59.9 years STANDARD_DEVIATION 12.99 |
| Age, Customized <=65 years | 671 participants |
| Age, Customized >=75 years | 141 participants |
| Age, Customized Between 65 and 75 years | 227 participants |
| Region of Enrollment United States | 1039 participants |
| Sex: Female, Male Female | 391 Participants |
| Sex: Female, Male Male | 648 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 69 / 1,039 |
| serious Total, serious adverse events | 5 / 1,039 |
Outcome results
Primary
The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice.
A Serious Adverse Reaction or (SAR) is considered causally related to the Optison product administered by the investigator. This reaction, should it occur, will be counted as a serious adverse reaction.
Time frame: Within 24 hours post contrast administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Optison | The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice. | 0 Serious Adverse Reactions |
Secondary
The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice.
The frequency of any serious adverse event (SAE) whether it is related to the Optison product or not, after the administration of the Optison product during contrast enhanced echocardiography.
Time frame: Within 24 hours post contrast administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Optison | The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice. | 6 Serious adverse events |