Summary

Eligibility
for people ages 20 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Acute Coronary Syndrome, Myocardial Infarction, Syndrome, Infarction, Elecsys® Troponin T hs Gen 6

Eligibility

You can join if…

Open to people ages 20 years and up

  • 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.

You CAN'T join if...

  • None

Locations

  • UCSD La Jolla ED
    La Jolla California 92037 United States
  • El Centro Regional Medical Center
    El Centro California 92243 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT06734117
Study Type
Observational
Participants
About 5429 people participating
Last Updated