COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Myocardial Infarction
- Sponsor
- Hennepin Healthcare Research Institute
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction.
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult, defined as subject 18 years of age or older
- •Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial cTnI measurement.
- •At least one 12-lead electrocardiogram
Exclusion Criteria
- •Currently pregnant
- •Trauma related admission
- •Cardiac arrest
- •Decline to participate
- •Did not present through the ED
- •Transferred from an outside hospital
Outcomes
Primary Outcomes
Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction.
Time Frame: on admission
Diagnostic performance of cardiac troponin assays for the diagnosis of acute myocardial injury and myocardial infarction
Secondary Outcomes
- All-cause mortality(Up to 180-days)
- Cardiac death(Up to 180-days)
- Unstable angina(Up to 180-days)
- Acute myocardial infarction(Up to 180-days)
- Revascularization(Up to 180-days)
- Safety outcome: Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.(30-days)