A Study of Elecsys® Troponin T Hs Gen 6 in Participants with Symptoms of Acute Coronary Syndrome

  • Cardiovascular Disorder
  • Myocardial Infarction
  • Acute Coronary Syndrome
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Austria
  • Bulgaria
  • China
  • Germany
  • Japan
  • Netherlands
  • Norway
  • Spain
  • Switzerland
  • United Kingdom
  • United States
Trial Identifier:

NCT06734117 CIM RD005477

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT06734117, CIM RD005477 Trial Identifier
      Elecsys® Troponin T hs Gen 6, Blood sample collection Treatments
      Acute Coronary Syndrome, Myocardial Infarction Condition
      Official Title

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

      Eligibility Criteria

      All Gender
      ≥20 Years Age
      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:
      • 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.
      Exclusion Criteria
      • None

      For the latest version of this information please go to www.forpatients.roche.com

       

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