A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
This study has been completed.
Sponsor:
Lantheus Medical Imaging
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00625365
First received: February 20, 2008
Last updated: October 14, 2011
Last verified: August 2011
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Purpose
The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease |
Other: Perflutren Lipid Microspheres (DEFINITY®) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | CARES (Contrast EchocArdiography REgistry for Safety Surveillance): A Prospective, Phase IV, Open-Label, Nonrandomized, Multicenter, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice |
Resource links provided by NLM:
Further study details as provided by Lantheus Medical Imaging:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Serious Adverse Events [ Time Frame: Through 24 hours ] [ Designated as safety issue: Yes ]Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration
- Adverse Events [ Time Frame: Through 24 hours ] [ Designated as safety issue: Yes ]Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration
| Enrollment: | 1060 |
| Study Start Date: | February 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Other: Perflutren Lipid Microspheres (DEFINITY®)
- DEFINITY
- Vial for (Perflutren Lipid Microsphere) injectable Suspension
DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert
Other Names:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625365
Locations
| United States, California | |
| UCSD Medical Center | |
| San Diego, California, United States, 92103-8411 | |
| United States, Delaware | |
| Alfieri Cardiology | |
| Newark, Delaware, United States, 19713 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611-2969 | |
| United States, Maine | |
| Maine Research Associates | |
| Auburn, Maine, United States, 04210 | |
| United States, Minnesota | |
| Park Nicolett Institute | |
| St Louis Park, Minnesota, United States, 55426 | |
| United States, Missouri | |
| Cardiovascular Consultants, P.C. | |
| Kansas City, Missouri, United States, 64111 | |
| St. Louis University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| St. Luke's-Roosevelt Hospital | |
| New York, New York, United States, 10025 | |
| Mt Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, North Dakota | |
| Meritcare Heart Center Cardiology | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| York Hospital | |
| York, Pennsylvania, United States, 17405 | |
| United States, Texas | |
| Consultants in Cardiology | |
| Fort Worth, Texas, United States, 76104 | |
| University of Texas Medical Center | |
| Galveston, Texas, United States, 77555 | |
| The Methodist DeBakey Heart Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
| Study Director: | Veronica Lee, MD | Lantheus Medical Imaging |
More Information
No publications provided
| Responsible Party: | Lantheus Medical Imaging |
| ClinicalTrials.gov Identifier: | NCT00625365 History of Changes |
| Other Study ID Numbers: | DMP 115-415 |
| Study First Received: | February 20, 2008 |
| Results First Received: | December 17, 2010 |
| Last Updated: | October 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Lantheus Medical Imaging:
|
DEFINITY Safety Survelliance |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013