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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625365
• Other study ID #: DMP 115-415
• Status: Completed
• Phase: Phase 4
• Start date: February 2008
• Est. completion date: July 2009

Study information

• Verified date: August 2011
• Source: Lantheus Medical Imaging
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1060
• Est. completion date: July 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• DEFINITY®
DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert

Locations

Country	Name	City	State
United States	Maine Research Associates	Auburn	Maine
United States	Northwestern University	Chicago	Illinois
United States	Meritcare Heart Center Cardiology	Fargo	North Dakota
United States	Consultants in Cardiology	Fort Worth	Texas
United States	University of Texas Medical Center	Galveston	Texas
United States	The Methodist DeBakey Heart Center	Houston	Texas
United States	Cardiovascular Consultants, P.C.	Kansas City	Missouri
United States	Mt Sinai Medical Center	New York	New York
United States	St. Luke's-Roosevelt Hospital	New York	New York
United States	Alfieri Cardiology	Newark	Delaware
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	St. Louis University	Saint Louis	Missouri
United States	Park Nicolett Institute	Saint Louis Park	Minnesota
United States	UCSD Medical Center	San Diego	California
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lantheus Medical Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serious Adverse Events	Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration	Through 24 hours
Secondary	Adverse Events	Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration	Through 24 hours