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

NCT06734117 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5429

Last updated 2025-01-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Roche Diagnostics GmbH

    collaborator INDUSTRY

  • Roche Diagnostics Operations, Inc.

    collaborator UNKNOWN

  • Hoffmann-La Roche

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2024-06-27
Completion
2024-12-26

Countries

  • United States
  • Austria
  • Bulgaria
  • China
  • Germany
  • Japan
  • Netherlands
  • Norway
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06734117 on ClinicalTrials.gov