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.
Sponsor:
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT01299649
First received: February 16, 2011
Last updated: February 17, 2011
Last verified: February 2011
  Purpose

Retrospective analysis to observe changes in short term mortality


Condition
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)
Groups/Cohorts
Non-contrast echocardiography
Non-contrast echocardiography
Contrast Echocardiography
Contrast Echocardiography

  Eligibility

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

Criteria

Inclusion Criteria:

  • Males and females
  • At least 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299649

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

No publications provided

ClinicalTrials.gov 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:
CAD

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014