A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice

Phase 4

Completed

• Conditions: Cardiovascular Disease
• Interventions: Drug: DEFINITY®

• Registration Number: NCT00625365
• Lead Sponsor: Lantheus Medical Imaging

Brief Summary

The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-27
• Study First Posted: 2008-02-28
• Primary Completion: 2009-05
• Study Completion: 2009-07
• Results First Submitted: 2010-12-17
• Results First Submitted QC: 2010-12-17
• Results First Posted: 2011-01-14
• Status Verified: 2011-08
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1060

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEFINITY® (Perflutren Lipid Microsphere)	DEFINITY®	Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Serious Adverse Events	Through 24 hours	Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration
Adverse Events	Through 24 hours	Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration

Trial Locations

Locations (16)

UCSD Medical Center; 🇺🇸 San Diego, California, United States

Alfieri Cardiology; 🇺🇸 Newark, Delaware, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Maine Research Associates; 🇺🇸 Auburn, Maine, United States

Park Nicolett Institute; 🇺🇸 Saint Louis Park, Minnesota, United States

Cardiovascular Consultants, P.C.; 🇺🇸 Kansas City, Missouri, United States

St. Louis University; 🇺🇸 Saint Louis, Missouri, United States

St. Luke's-Roosevelt Hospital; 🇺🇸 New York, New York, United States

Mt Sinai Medical Center; 🇺🇸 New York, New York, United States

Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

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