A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY� in Clinical Practice
Information source: Lantheus Medical Imaging
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Disease
Intervention: Perflutren Lipid Microspheres (DEFINITY®) (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Lantheus Medical Imaging Official(s) and/or principal investigator(s): Veronica Lee, MD, Study Director, Affiliation: Lantheus Medical Imaging
Summary
The purpose of this registry study is to gather safety information on the current clinical
use of and the safety of DEFINITY®
Clinical Details
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
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration
Secondary outcome: Serious Adverse EventsAdverse Events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
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, St 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
Mt Sinai Medical Center, New York, New York 10029, United States
St. Luke's-Roosevelt Hospital, New York, New York 10025, 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
Additional Information
Starting date: February 2008
Last updated: October 14, 2011
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