NCT06734117

A Study of Elecsys® Troponin T hs Gen 6 in Participants With Symptoms of Acute Coronary Syndrome

Clinical Performance of Elecsys® Troponin T hs Gen 6 in Subjects With Symptoms of Acute Coronary Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,429 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This prospective, non-interventional, single arm, longitudinal cohort multicenter study will recruit approximately 5600 consecutive all-comers, consisting of patients with signs and symptoms of acute coronary syndromes (ACS) who present in the emergency department (ED). The main objective of the study is to determine the clinical performance of Elecsys Troponin T hs Gen 6 versus the centrally adjudicated clinical diagnosis at various time points after ED presentation using the previously determined clinical cut-off of a universal 99th percentile upper reference limit.

Conditions

• Acute Coronary Syndrome
• Myocardial Infarction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Elecsys® Troponin T hs Gen 6	It is an immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in human serum and plasma using cobas e platforms. This investigational immunoassay is intended to aid in the diagnosis of myocardial infarction.
PROCEDURE	Blood sample collection	Blood will be collected from each recruited individual by a healthcare practitioner at five time points after emergency department presentation.

Timeline

• Start date: 2021-11-15
• Primary completion: 2024-06-27
• Completion: 2024-12-26
• First posted: 2024-12-16
• Last updated: 2025-01-24

Locations

50 sites across 11 countries: United States, Austria, Bulgaria, China, Germany, Japan, Netherlands, Norway, Spain, Switzerland, United Kingdom