A Study of Elecsys® Troponin T hs Gen 6 in Participants With Symptoms of Acute Coronary Syndrome (PERFORM-TSIX)

Roche

Status: Completed

Conditions: Acute Coronary Syndrome; Myocardial Infarction

Treatments: Procedure: Blood sample collection; Diagnostic Test: Elecsys® Troponin T hs Gen 6

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06734117

CIM RD005477

Details and patient eligibility

About

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.

Enrollment: 5,429 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥20 years

• Signed Informed Consent Form

• Troponin or other cardiac marker determination planned as part of suspected acute coronary syndromes routine care

• Demonstrating symptoms suggestive of acute coronary syndrome and/or myocardial ischemia, such as any of the following:

  1. Chest pain, pressure, or a burning sensation across the precordium and epigastrium;
  2. Pain that radiates to neck, shoulder, jaw, back, upper abdomen, or either arm;
  3. Acute onset or worsening dyspnea;
  4. Nausea, vomiting or indigestion;
  5. Lightheadedness or syncope;
  6. Diaphoresis;
  7. Generalized weakness or fatigue; OR, asymptomatic subjects or patients with atypical symptoms in whom myocardial infarction is being suspected.

Exclusion criteria

• None

Trial design

5,429 participants in 1 patient group

Participants With Signs and Symptoms of Acute Coronary Syndromes

Description:

The study population will be a consecutive all-comers cohort consisting of patients with signs and symptoms of acute coronary syndromes presenting to the emergency department. Participants will be diagnosed and treated according to the local standard of care at the study site.

Treatment:

Diagnostic Test: Elecsys® Troponin T hs Gen 6

Procedure: Blood sample collection