Cardiovascular Disease
Conditions
Keywords
DEFINITY, Safety, Survelliance
Brief summary
The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®
Interventions
DRUGDEFINITY®
DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert
Sponsors
Lantheus Medical Imaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who, in the investigator's opinion, require DEFINITY® echocardiography due to suboptimal, unenhanced images.
Exclusion criteria
* Known hypersensitivity to perflutren, DEFINITY®, or other echo contrast agent. * Prior SAE associated with perflutren, DEFINITY®, or administration of other echo contrast agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration | during or within 30 minutes of administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | Through 24 hours | Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration |
| Adverse Events | Through 24 hours | Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from hospitals and clinics in the USA between February 2008 and April 2009
Pre-assignment details
There were no pre-assignment requirements for this study
Participants by arm
| Arm | Count |
|---|---|
| DEFINITY (Perflutren Lipid Microsphere) Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography | 1,053 |
| Total | 1,053 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No IV access | 5 |
| Overall Study | VSD | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | DEFINITY (Perflutren Lipid Microsphere) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 444 Participants |
| Age, Categorical Between 18 and 65 years | 609 Participants |
| Age, Continuous | 61.3 years STANDARD_DEVIATION 12.9 |
| Sex: Female, Male Female | 400 Participants |
| Sex: Female, Male Male | 653 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 1,053 |
| serious Total, serious adverse events | 0 / 1,053 |
Outcome results
Primary
The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration
Time frame: during or within 30 minutes of administration
Population: The safety population was analyzed per the protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DEFINITY® | The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration | 0 Participants |
Secondary
Adverse Events
Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration
Time frame: Through 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DEFINITY® | Adverse Events | 114 Participants |
Secondary
Serious Adverse Events
Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration
Time frame: Through 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DEFINITY® | Serious Adverse Events | 0 Participants |