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OpenTrials
Completed

NCT Number: NCT02285686

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recruitment rate

    Time frame: 1 month

    Feasibility outcome

  2. Data collection time per patient

    Time frame: 3 months

    Feasibility outcome

  3. rate of successful deferred informed consent definition

    Time frame: 1 month

    Feasibility outcome

Secondary outcomes

  1. All-cause in-hospital mortality

    Time frame: 3 months

  2. Troponin elevations

    Time frame: 3 months

  3. Myocardial infarction

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Acronym: PRO-TROPICS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 7, 2014
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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