Phase 4
Completed N=1,039
A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.
Echocardiography
Source: ClinicalTrials.gov NCT00730964 ↗
Enrolled (actual)
1,039
Serious AEs
0.5%
Results posted
Jun 2012
Primary outcomePrimary: 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
Summary
This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
— | — |
| 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. |
6 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00730964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.