Retrospective Safety Study to Compare Mortality in Intensive Care Unite (ICU) Patients Undergoing Echocardiography With or Without DEFINITY® (DEF-418)

This study has been completed.
Information provided by:
Lantheus Medical Imaging Identifier:
First received: February 16, 2011
Last updated: February 17, 2011
Last verified: February 2011

Retrospective analysis to observe changes in short term mortality

Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Retrospective Observational Database Study To Compare In-Hospital All-Cause Mortality in Critically Ill Patients Undergoing Echocardiography With or Without DEFINITY®

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • Short term mortality [ Time Frame: 48 hours post echo produre ] [ Designated as safety issue: Yes ]

Enrollment: 4300000
Study Start Date: June 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Non-contrast echocardiography
Non-contrast echocardiography
Contrast Echocardiography
Contrast Echocardiography


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All that received an echocardiogram


Inclusion Criteria:

  • Males and females
  • At least 18 years of age
  Contacts and Locations
Please refer to this study by its identifier: NCT01299649

United States, Massachusetts
Lantheus Medical Imaging
N. Billerica, Massachusetts, United States, 01862
Sponsors and Collaborators
Lantheus Medical Imaging
  More Information

No publications provided Identifier: NCT01299649     History of Changes
Other Study ID Numbers: DMP 115-418
Study First Received: February 16, 2011
Last Updated: February 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:

Additional relevant MeSH terms:
Cardiovascular Diseases processed this record on April 17, 2014