A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
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
1 other identifier
interventional
1,060
1 country
16
Brief Summary
The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2008
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
January 14, 2011
CompletedNovember 24, 2020
August 1, 2011
1.2 years
February 20, 2008
December 17, 2010
November 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Serious Adverse Events
Through 24 hours
Adverse Events
Through 24 hours
Study Arms (1)
DEFINITY® (Perflutren Lipid Microsphere)
OTHERPatients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Interventions
DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert
Eligibility Criteria
You may qualify if:
- Patients who, in the investigator's opinion, require DEFINITY® echocardiography due to suboptimal, unenhanced images.
You may not qualify if:
- Known hypersensitivity to perflutren, DEFINITY®, or other echo contrast agent.
- Prior SAE associated with perflutren, DEFINITY®, or administration of other echo contrast agent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
UCSD Medical Center
San Diego, California, 92103-8411, United States
Alfieri Cardiology
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
MeSH Terms
Conditions
Interventions
Results Point of Contact
- Title
- Dana Washburn, M.D.
- Organization
- Lantheus Medical Imaging
Study Officials
- STUDY DIRECTOR
Veronica Lee, MD
Lantheus Medical Imaging
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2008
First Posted
February 28, 2008
Study Start
February 1, 2008
Primary Completion
May 1, 2009
Study Completion
July 1, 2009
Last Updated
November 24, 2020
Results First Posted
January 14, 2011
Record last verified: 2011-08