COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial



Status:Active, not recruiting
Conditions:Cardiology, Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:12/20/2018
Start Date:November 6, 2017
End Date:December 31, 2019

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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

Inclusion Criteria:

1. Adult, defined as subject 18 years of age or older

2. Baseline cTn measurement and at least one additional cTn measurement within 6 hours
after initial cTnI measurement.

3. At least one 12-lead electrocardiogram

Exclusion Criteria:

1. Currently pregnant

2. Trauma related admission

3. Cardiac arrest

4. Decline to participate

5. Did not present through the ED

6. Transferred from an outside hospital
We found this trial at
1
site
Minneapolis, Minnesota 55414
Phone: 612-873-6893
?
mi
from
Minneapolis, MN
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