NCT03214029

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Hennepin Healthcare Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Conditions

• Acute Myocardial Infarction
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiac troponin testing	Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays.

Timeline

• Start date: 2017-11-06
• Primary completion: 2022-12-31
• Completion: 2025-12-31
• First posted: 2017-07-11
• Last updated: 2024-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study