Myocardial Infarction Clinical Trial
— PRO-TROPICSOfficial title:
Prognostic Value of Elevated Troponins in Critical Illness Study: A Pilot Study
Verified date | October 2017 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
McMaster University |
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 |
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