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Clinical Trials/NCT02285686
NCT02285686CompletedNot Applicable

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

McMaster University0 sites251 target enrollmentStarted: November 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
251
Primary Endpoint
Recruitment rate

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Recruitment rate

Time Frame: 1 month

Feasibility outcome

rate of successful deferred informed consent definition

Time Frame: 1 month

Feasibility outcome

Data collection time per patient

Time Frame: 3 months

Feasibility outcome

Secondary Outcomes

  • All-cause in-hospital mortality(3 months)
  • Myocardial infarction(3 months)
  • Troponin elevations(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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