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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56428

Enrollment

100

Registered

2022-11-29

Start date

2023-01-25

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute coronoaire syndrome myocardial infarction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
primary endpoint: Negative predictive value (NPV) of troponin Ths measured by the 6th generation test at T3	—

Secondary

Measure	Time frame
clinical performance of troponin Ths gene 6 at other time points after admission Performance of the troponin Ths gene 6 assay when the assay is used in the rapid rule-out algorithm as described by the European Society of Cardiology (ESC)	—

Countries

Netherlands

Outcome results