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The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEFINITY® (Perflutren Lipid Microsphere) | Other | Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEFINITY® | Drug | DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration | Through 24 hours |
| Adverse Events |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Veronica Lee, MD | Lantheus Medical Imaging | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | San Diego | California | 92103-8411 | United States | ||
| Alfieri Cardiology |
There were no pre-assignment requirements for this study
Participants were recruited from hospitals and clinics in the USA between February 2008 and April 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | DEFINITY® | Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration
| Through 24 hours |
| Newark |
| Delaware |
| 19713 |
| United States |
| Northwestern University | Chicago | Illinois | 60611-2969 | United States |
| Maine Research Associates | Auburn | Maine | 04210 | United States |
| Park Nicolett Institute | Saint Louis Park | Minnesota | 55426 | United States |
| Cardiovascular Consultants, P.C. | Kansas City | Missouri | 64111 | United States |
| St. Louis University | St Louis | Missouri | 63110 | United States |
| St. Luke's-Roosevelt Hospital | New York | New York | 10025 | United States |
| Mt Sinai Medical Center | New York | New York | 10029 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Meritcare Heart Center Cardiology | Fargo | North Dakota | 58122 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| York Hospital | York | Pennsylvania | 17405 | United States |
| Consultants in Cardiology | Fort Worth | Texas | 76104 | United States |
| University of Texas Medical Center | Galveston | Texas | 77555 | United States |
| The Methodist DeBakey Heart Center | Houston | Texas | 77030 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration | The safety population was analyzed per the protocol | Posted | Number | Participants | during or within 30 minutes of administration |
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| Secondary | Serious Adverse Events | Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration | Posted | Number | Participants | Through 24 hours |
|
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| Secondary | Adverse Events | Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration | Posted | Number | Participants | Through 24 hours |
|
|
Through 24 hours post last dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DEFINITY® | Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography | 0 | 1,053 | 35 | 1,053 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Washburn, M.D. | Lantheus Medical Imaging | 978-671-8686 | dana.washburn@lantheus.com |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C042852 | perflutren |
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| Title | Denominators | Categories |
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| Title | Denominators | Categories |
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