A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.

Study Overview
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Brief Summary
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This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.

Official Title
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A Post-marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice

Conditions
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Echocardiography

Intervention / Treatment
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* Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Phase 4<br>Open Label | Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)<br>* 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.<br>* Other names: Optison;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 24 hours post contrast administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 24 hours post contrast administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surveillance, Optison, Perflutren, Echocardiography, Subjects receive Optison during enhanced echocardiography