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| Name | Class |
|---|---|
| Abbott Diagnostics Division | INDUSTRY |
| Hennepin County Medical Center, Minneapolis | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population | Prospective, observational cohort study of consecutives patients (goal, 2000 patients over 5 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac troponin testing | Diagnostic Test | Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | on admission |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Any death | Up to 180-days |
| Cardiac death | Death due to cardiac reasons. | Up to 180-days |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients (goal, 2000 patients over 5 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.
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| Name | Affiliation | Role |
|---|---|---|
| Fred S Apple, PhD | Hennepin County Medical Center and Minneapolis Medical Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Excess blood is biobanked as EDTA-plasma and heparin samples after being used for the clinical cTnI assay
| Unstable angina | Diagnosis of unstable angina per chart review up to 180-days | Up to 180-days |
| Acute myocardial infarction | Diagnosis of Acute myocardial infarction per chart review up to 180 days. | Up to 180-days |
| Revascularization | Coronary artery bypass graft surgery or percutaneous coronary intervention | 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. | 30-days |