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

Completed

Conditions studied: Acute Coronary Syndrome, Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT06734117

Run by

Hoffmann-La Roche

People needed

5429

Starts

2021-11-15

Expected to finish

2024-12-26

Last updated by the study team

2025-01-24

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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; OR, asymptomatic subjects or patients with atypical symptoms in whom myocardial infarction is being suspected.

You may not qualify if…

• None

Where it is running

• El Centro Regional Medical Center — El Centro, California, United States
• UCSD La Jolla ED — La Jolla, California, United States
• University of Florida — Gainesville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Parkview Research — Fort Wayne, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Henry Ford Health — Detroit, Michigan, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• University at Buffalo / Buffalo General Hospital — Buffalo, New York, United States
• University of Buffalo - Erie County Medical Center — Buffalo, New York, United States
• Long Island Jewish Medical Center — New Hyde Park, New York, United States
• Atrium Health — Charlotte, North Carolina, United States
• Duke Regional Hospital — Durham, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Atrium Health Wake Forest Baptist, High Point Medical Center — High Point, North Carolina, United States
• Wake Forest Health Sciences — Winston-Salem, North Carolina, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• MUSC Health Florence Medical Center — Florence, South Carolina, United States
• Dallas VA Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• Eastside Research Associates — Redmond, Washington, United States
• MultiCare Institute for Research & Innovation — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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