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

Myocardial Infarction Clinical Trial

— PRO-TROPICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285686
• Other study ID #: 14-674
• Secondary ID: 14348
• Status: Completed
• Phase: N/A
• First received: November 5, 2014
• Last updated: October 30, 2017
• Start date: November 2014
• Est. completion date: March 30, 2015

Study information

• Verified date: October 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: March 30, 2015
• Est. primary completion date: March 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Critical Illness
• Infarction
• Myocardial Infarction
• Troponin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Feasibility outcome	1 month
Primary	Data collection time per patient	Feasibility outcome	3 months
Primary	rate of successful deferred informed consent definition	Feasibility outcome	1 month
Secondary	All-cause in-hospital mortality		3 months
Secondary	Troponin elevations		3 months
Secondary	Myocardial infarction		3 months