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

Recruiting

• Conditions: acute coronoaire syndrome; myocardial infarction; 10011082

• Registration Number: NL-OMON56428
• Lead Sponsor: Roche Diagnostics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Signed Informed Consent
Age >=20 Years
Subjects demonstrating symptoms suggestive of acute coronary syndrome and/or
myocardial ischemia, such as any of the following:
Chest pain, pressure, or a burning sensation across the precordium and
epigastrium
Pain that radiates to neck, shoulder, jaw, back, upper abdomen, or either arm
Acute onset or worsening dyspnea
Nausea, vomiting, or indigestion
Lightheadedness or syncope
Diaphoresis
Generalized weakness or fatigue
Troponin or other cardiac marker determination planned as part of suspected ACS
routine care
Asymptomatic subjects with atypical symptoms in whom myocardial infarction is
being suspected

Exclusion Criteria

none

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>primary endpoint: Negative predictive value (NPV) of troponin Ths measured by<br /><br>the 6th generation test at T3</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>clinical performance of troponin Ths gene 6 at other time points after admission<br /><br>Performance of the troponin Ths gene 6 assay when the assay is used in the<br /><br>rapid rule-out algorithm as described by the European Society of Cardiology<br /><br>(ESC)</p><br>