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

NCT06734117

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Acute Coronary Syndrome, Myocardial Infarction

Interventions: Elecsys® Troponin T hs Gen 6, Blood sample collection

Countries: United States, Austria, Bulgaria, China, Germany, Japan, Netherlands, Norway

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.

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (50)
  • El Centro, California, United States
  • La Jolla, California, United States
  • Gainesville, Florida, United States
  • Tampa, Florida, United States
  • Fort Wayne, Indiana, United States
  • Kansas City, Kansas, United States
  • Detroit, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Buffalo, New York, United States
  • Buffalo, New York, United States
  • New Hyde Park, New York, United States
  • Charlotte, North Carolina, United States
  • Durham, North Carolina, United States
  • Durham, North Carolina, United States
  • High Point, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Oklahoma City, Oklahoma, United States
  • Charleston, South Carolina, United States
  • Florence, South Carolina, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Falls Church, Virginia, United States
  • Norfolk, Virginia, United States
  • Redmond, Washington, United States
  • Tacoma, Washington, United States
  • Wausau, Wisconsin, United States
  • Vienna, Austria
  • Burgas, Bulgaria
  • Pleven, Bulgaria
  • Beijing, China
  • + 20 more on CT.gov