Clinical trial NCT00625365: A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disease
Keywords: DEFINITY
Safety
Survelliance
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2008-02-28
Enrollment: 1060
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility 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.

Primary outcomes:
measure: The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration
timeFrame: during or within 30 minutes of administration
Secondary outcomes:
measure: Serious Adverse Events
timeFrame: Through 24 hours
measure: Adverse Events
timeFrame: Through 24 hours
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Newark
country: United States
facility: Alfieri Cardiology
state: Delaware
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Saint Louis Park
country: United States
facility: Park Nicolett Institute
state: Minnesota
city: Kansas City
country: United States
facility: Cardiovascular Consultants, P.C.
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital
state: New York
city: New York
country: United States
facility: Mt Sinai Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Meritcare Heart Center Cardiology
state: North Dakota
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Fort Worth
country: United States
facility: Consultants in Cardiology
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Center
state: Texas
city: Houston
country: United States
facility: The Methodist DeBakey Heart Center
state: Texas
Study officials:
affiliation: Lantheus Medical Imaging
name: Veronica Lee, MD
role: STUDY_DIRECTOR
References: