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

Sponsor
Lantheus Medical Imaging (Industry)
Overall Status
Completed
CT.gov ID
NCT01299649
Collaborator
(none)
4,300,000
Enrollment
1
Location
6
Duration (Months)
715198.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retrospective analysis to observe changes in short term mortality

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    4300000 participants
    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®
    Study Start Date :
    Jun 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2008
    Actual Study Completion Date :
    Dec 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    Non-contrast echocardiography

    Non-contrast echocardiography
    Contrast Echocardiography

    Contrast Echocardiography

    Outcome Measures

    Primary Outcome Measures

    1. Short term mortality [48 hours post echo produre]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Males and females

    • At least 18 years of age

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lantheus Medical Imaging N. Billerica Massachusetts United States 01862

    Sponsors and Collaborators

    • Lantheus Medical Imaging

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lantheus Medical Imaging
    ClinicalTrials.gov Identifier:
    NCT01299649
    Other Study ID Numbers:
    • DMP 115-418
    First Posted:
    Feb 18, 2011
    Last Update Posted:
    Nov 10, 2020
    Last Verified:
    Feb 1, 2011
    Keywords provided by Lantheus Medical Imaging
    CAD
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Nov 10, 2020