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PRO-TROPICS: Prognostic Value of Elevated Troponins in Critical Illness Study: A Pilot Study

Sponsor
McMaster University (Other)
Overall Status
Completed
CT.gov ID
NCT02285686
Collaborator
(none)
251
Enrollment
4.9
Duration (Months)

Study Details

Study Description

Brief Summary

Troponins are sensitive and specific markers of cardiac injury. Critically ill patients frequently have elevated troponins. In this population, distinguishing patients with elevated troponins from those with myocardial infarction is difficult. However, troponin elevations on their own seem to be associated with an increased risk of death. The optimal treatment of patients with type 2 myocardial infarction or non ischemia related troponin elevations during critical illness is unclear. There are no trials in the ICU setting to guide management.

This study is a 1-month pilot cohort study of troponin screening in 4 Ontario intensive care units. The objective of this pilot study is to evaluate the ability to perform a larger study, which will determine the prevalence, incidence and risk factors for elevated troponin values, how patients with elevated troponin values are treated as a baseline, and the incidence of myocardial infarction in critically ill patients. Knowing the prognostic impact of these conditions and understanding current management will thereafter guide researchers and clinicians on the importance of carefully evaluating potential risk-modifying therapies.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    251 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prognostic Value of Elevated Troponins in Critical Illness Study: A Pilot Study
    Study Start Date :
    Nov 1, 2014
    Actual Primary Completion Date :
    Mar 15, 2015
    Actual Study Completion Date :
    Mar 30, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Recruitment rate [1 month]

      Feasibility outcome

    2. Data collection time per patient [3 months]

      Feasibility outcome

    3. rate of successful deferred informed consent definition [1 month]

      Feasibility outcome

    Secondary Outcome Measures

    1. All-cause in-hospital mortality [3 months]

    2. Troponin elevations [3 months]

    3. Myocardial infarction [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All adult patients admitted to the participating ICUs of study sites during the study enrollment period will be eligible.
    Exclusion Criteria:

    • Patients who are admitted and die or are discharged within 12 hours

    • Patients re-admitted to ICU during the index ICU enrolment month

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • McMaster University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    McMaster University
    ClinicalTrials.gov Identifier:
    NCT02285686
    Other Study ID Numbers:
    • 14-674
    • 14348
    First Posted:
    Nov 7, 2014
    Last Update Posted:
    Nov 1, 2017
    Last Verified:
    Oct 1, 2017
    Keywords provided by McMaster University
    troponin
    biomarkers
    myocardial infarction
    critical illness
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction
    Critical Illness

    Study Results

    No Results Posted as of Nov 1, 2017