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

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 Overview

• Status: Completed
• Conditions: Myocardial Infarction; Critical Care; Troponin

• Study Type: Observational
• Enrollment (Actual): 251

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Feasibility outcome	1 month
Data collection time per patient	Feasibility outcome	3 months
rate of successful deferred informed consent definition	Feasibility outcome	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause in-hospital mortality	3 months
Troponin elevations	3 months
Myocardial infarction	3 months

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): March 15, 2015
• Study Completion (Actual): March 30, 2015

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 7, 2014

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: biomarkers; myocardial infarction; critical illness; troponin
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Myocardial Infarction; Infarction; Critical Illness
• Other Study ID Numbers: 14-674; 14348 (Other Grant/Funding Number: Hamilton Health Sciences - New Investigator Fund)