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

Completed

• Conditions: Critical Care; Myocardial Infarction; Troponin

• Registration Number: NCT02285686
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-07
• Primary Completion: 2015-03-15
• Study Completion: 2015-03-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

• All adult patients admitted to the participating ICUs of study sites during the study enrollment period will be eligible.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment rate	1 month	Feasibility outcome
rate of successful deferred informed consent definition	1 month	Feasibility outcome
Data collection time per patient	3 months	Feasibility outcome

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction	3 months
Troponin elevations	3 months
All-cause in-hospital mortality	3 months