Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
Background: Comparative studies addressing the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in consecutive patients presenting to a United States (US) emergency department are lacking. Study objective: Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication. Null Hypothesis: hs-cTnI and or hs-cTnT assays will offer comparable diagnostic performance for acute myocardial injury and acute myocardial
Study Type
OBSERVATIONAL
Enrollment
2,000
Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays.
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction.
Diagnostic performance of cardiac troponin assays for the diagnosis of acute myocardial injury and myocardial infarction
Time frame: on admission
All-cause mortality
Any death
Time frame: Up to 180-days
Cardiac death
Death due to cardiac reasons.
Time frame: Up to 180-days
Unstable angina
Diagnosis of unstable angina per chart review up to 180-days
Time frame: Up to 180-days
Acute myocardial infarction
Diagnosis of Acute myocardial infarction per chart review up to 180 days.
Time frame: Up to 180-days
Revascularization
Coronary artery bypass graft surgery or percutaneous coronary intervention
Time frame: Up to 180-days
Safety outcome: Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.
Safety outcome for tested diagnostic strategies will be defined at 30-days, including index hospitalization events for MACE - Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.
Time frame: 30-days
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