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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 Events

Adverse 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

Page last updated: August 20, 2015

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