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The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.
This Phase IV safety study will provide safety data on potential systemic and pulmonary hemodynamic effects caused by the administration of DEFINITY® in patients who are to undergo right heart cardiac catheterization for clinical reasons. Using a right heart catheter for direct measurements of pulmonary artery hemodynamics will allow accurate assessments of potential alterations of the pulmonary vasculature. This will be further investigated by the inclusion of two patient populations, one with a baseline pulmonary artery pressure < 35 mmHg, and one with elevated baseline pulmonary artery pressure. The addition of immune parameter measurements will assess a potential link between systemic and pulmonary alterations and potential immune reactions following DEFINITY® administration.
The inclusion of patients in this study is not based on a required echocardiogram with DEFINITY® administration because patients would be exposed to an unjustifiable risk of invasive right heart catheterization and are unlikely to consent to such a procedure. Therefore, patients undergoing heart catheterization for clinical reasons, or patients who are undergoing pulmonary artery hemodynamic assessments will be enrolled and receive DEFINITY® in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Pulmonary Arterial Pressure | Experimental | Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg. |
|
| Elevated Pulmonary Arterial Pressure | Experimental | Subjects with a PAP of > or = to 35 mmHg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Definity | Drug | one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose | Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose | 31-35 minutes minus baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Immunology Panel- Complement 3A (C3A) | Evaluate the Immunology Panel after the administration of DEFINITY | Out to 70 minutes |
| Immunology Panel- Complement 5A(C5A) | Evaluate the Immunology Panel after the administration of DEFINITY |
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Inclusion Criteria:
Appropriate candidate scheduled to undergo right heart catheterization and measurement of pulmonary artery hemodynamics for clinical reasons
Be male or female above the age of 18
Female patients who no longer have child-bearing potential
Women of Child-Bearing Potential(WOCBP) who:
Be able and willing to communicate effectively with study center personnel.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veronica Lee, MD | Lantheus Medical Imaging | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States | ||
| University of Chicago Medical Center |
There were no randomization procedures or other pre-assignment requirements in this study.
participants were recruited from hospitals and clinics in the USA between July 2009 and December 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Pulmonary Arterial Pressure | Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg. |
| FG001 | Elevated Pulmonary Arterial Pressure | Subjects with a PAP of > or = to 35 mmHg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Pulmonary Arterial Pressure | Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg. |
| BG001 | Elevated Pulmonary Arterial Pressure | Subjects with a PAP of > or = to 35 mmHg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose | Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose | Per the protocol | Posted | Mean | Standard Deviation | mm Hg | 31-35 minutes minus baseline |
|
Through 32 hours
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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 | Low Pulmonary Arterial Pressure | Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | MedDRA (11.0) | 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 |
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| ID | Term |
|---|---|
| D011660 | Pulmonary Heart Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C042852 | perflutren |
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|
| Out to 70 minutes |
| Immunology Panel- Interleuken-6 | Evaluate the Immunology Panel after the administration of DEFINITY | Out to 70 minutes |
| Immunology Panel- Tryptase | Evaluate the Immunology Panel after the administration of DEFINITY | Out to 70 minutes |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Methodist Hospital | Saint Louis Park | Minnesota | 55426 | United States |
| Cardiovascular Consultants | Kansas City | Missouri | 64111 | United States |
| Holy Name Hospital | Teaneck | New Jersey | 07666 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | United States |
| The University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pulmonary artery pressure 1 minute pre-dose | Mean | Standard Deviation | mm Hg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Immunology Panel- Complement 3A (C3A) | Evaluate the Immunology Panel after the administration of DEFINITY | Posted | Mean | Standard Deviation | ng/ml | Out to 70 minutes |
|
|
|
| Secondary | Immunology Panel- Complement 5A(C5A) | Evaluate the Immunology Panel after the administration of DEFINITY | Posted | Mean | Standard Deviation | ng/ml | Out to 70 minutes |
|
|
|
| Secondary | Immunology Panel- Interleuken-6 | Evaluate the Immunology Panel after the administration of DEFINITY | Posted | Mean | Standard Deviation | pg/ml | Out to 70 minutes |
|
|
|
| Secondary | Immunology Panel- Tryptase | Evaluate the Immunology Panel after the administration of DEFINITY | Posted | Mean | Standard Deviation | ug/ml | Out to 70 minutes |
|
|
|
| 0 |
| 16 |
| 4 |
| 16 |
| EG001 | Elevated Pulmonary Arterial Pressure | Subjects with a PAP of > or = to 35 mmHg. | 0 | 16 | 5 | 16 |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
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