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Sixth Generation High-sensitivity Cardiac Troponin T for the Early Rule Out of Myocardial Infarction: a Controlled Before and After Study (STEREO-MI)

6 juillet 2026 mis à jour par: University of Edinburgh

Cardiac troponin is a protein released into the blood when the heart muscle is damaged. Measuring this protein helps doctors diagnose a heart attack (also called a myocardial infarction). Modern blood tests, known as high-sensitivity cardiac troponin assays, can detect very small amounts of this protein.

A new version of this test, called Troponin T high-sensitivity Gen 6, has recently been developed and approved for use. It is designed to be more accurate and reliable, detecting smaller changes in troponin levels and being less affected by technical interference. The investigators believe this improved test will allow doctors to diagnose heart attacks more quickly and decide sooner who needs to stay in hospital and who can safely go home. This could help reduce overcrowding in Accident and Emergency (A&E) departments, a major challenge for the NHS.

This study will examine whether switching to this new test across a health board shortens the time patients with suspected heart attacks spend in the Emergency Department. The investigators will use information from the DataLoch Heart Disease Registry, which automatically collects anonymised hospital data for patients attending with possible heart attacks. The investigators will compare data from one year before and one year after implementation to see whether average length of stay changes and to confirm that patient safety remains high. This investigators will also measure both the current and new versions of the troponin test in surplus blood samples collected during two six-month periods-one before and one after the new test is introduced. This will allows the investigators to directly compare the two tests reliably.

Patients will not need to do anything extra to take part - the study uses information and samples already collected as part of their usual care.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

19500

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Andrew R Chapman, MD PhD
  • Numéro de téléphone: +44131 242 6200
  • E-mail: a.r.chapman@ed.ac.uk

Lieux d'étude

  • Royaume-Uni
    • Midlothian
      • Edinburgh, Midlothian, Royaume-Uni, EH4 2XU
        • Recrutement
        • Western General Hospital
        • Contact:
        • Chercheur principal:
          • Andrew R Chapman, MD PhD
      • Edinburgh, Midlothian, Royaume-Uni, EH16 4SA
        • Recrutement
        • The Royal Infirmary of Edinburgh
        • Contact:
        • Chercheur principal:
          • Andrew R Chapman, MD PhD
    • West Lothian
      • Livingston, West Lothian, Royaume-Uni, EH54 6PP
        • Recrutement
        • St. John's Hospital
        • Contact:
        • Chercheur principal:
          • Andrew R Chapman, MD PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Age 18 years and over.
  • Attending clinician suspects acute coronary syndrome.
  • At least one measurement of cardiac troponin using the Gen 5 or Gen 6 hs-cTnT assay.

Exclusion Criteria:

  • Insufficient clinical information to perform record linkage.
  • Not resident in Scotland.
  • Previous enrolment in the study.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Pre-implementation
Consecutive patients presenting with suspected acute coronary syndrome for 12 months prior to the implementation of the sixth generation hs-cTnT assay will be enrolled into the "pre-implementation" arm, where care is guided by the current, fifth-generation assay
Test diagnostique: fifth-generation high sensitivity cardiac troponin T assay
Elecsys Troponin T Gen 5 is an immunoassay for the in vitro quantitative determination of cardiac troponin T in human serum and plasma, that can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g. acute myocardial infarction (AMI). It is the most widely used high-sensitivity troponin assay globally.
Autres noms:
  • Troponin T gen 5
Expérimental: Post-implementation
Consecutive patients presenting with suspected acute coronary syndrome for 12 months after the implementation of the sixth generation hs-cTnT assay will be enrolled into the "post-implementation" arm, where care is guided by the sixth-generation assay
Test diagnostique: sixth-generation high sensitivity cardiac troponin T assay
Elecsys Troponin T hs Gen 6 is an immunoassay for the in vitro quantitative determination of cardiac troponin T in human serum and plasma, that can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g. acute myocardial infarction (AMI). In contrast to the previous generation of the assay (Elecsys Troponin T hs), the Gen 6 assay has been standardised against recombinant human cardiac troponin T, and has been demonstrated to have greater analytical precision and resistance to interference.
Autres noms:
  • Troponin T high sensitivity generation six
  • TnT hs Gen 6

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Length of stay within the Emergency Department
Délai: From Emergency Department arrival until Emergency Department discharge or hospital admission, up to 7 days
Length of stay within the Emergency Department, defined as the time from arrival until discharge from the Emergency Department or referral for admission to hospital.
From Emergency Department arrival until Emergency Department discharge or hospital admission, up to 7 days

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Length of hospital stay
Délai: From initial presentation until hospital discharge, up to 1 year
Total length of hospital stay from presentation until discharge from hospital
From initial presentation until hospital discharge, up to 1 year
Hospital admission
Délai: From initial presentation to the Emergency Department up to 7 days
Admission to hospital during index presentation
From initial presentation to the Emergency Department up to 7 days
Serial cardiac troponin measurements
Délai: From initial presentation until hospital discharge, up to 1 year
Number of serial cardiac troponin measurements during index admission
From initial presentation until hospital discharge, up to 1 year
Cardiovascular death at 30 days
Délai: From initial presentation until 30 days after initial presentation
Cardiovascular death at 30 days following presentation defined according to the Standardized Data Collection for Cardiovascular Trials Initiative: deaths that result from an AMI, sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to CV procedures, death due to CV hemorrhage, and death due to other CV causes (ICD10 codes I00-I99, limited to positions 1 or 2 in the record of death)
From initial presentation until 30 days after initial presentation
Cardiovascular death at 1 year
Délai: From initial presentation until 1 year after initial presentation
Cardiovascular death at 30 days following presentation defined according to the Standardized Data Collection for Cardiovascular Trials Initiative: deaths that result from an AMI, sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to CV procedures, death due to CV hemorrhage, and death due to other CV causes (ICD10 codes I00-I99, limited to positions 1 or 2 in the record of death)
From initial presentation until 1 year after initial presentation
Myocardial infarction after discharge at 30 days
Délai: From initial hospital discharge until 30 days following index presentation
Myocardial infarction following discharge from hospital at 30 days (a hospital episode recorded in the Scottish Morbidity Record associated with ICD10 codes I21 or I22, limited to position 1 or 2 on the discharge list)
From initial hospital discharge until 30 days following index presentation
Myocardial infarction after discharge at 1 year
Délai: From initial hospital discharge until 1 year following index presentation
Myocardial infarction following discharge from hospital at 30 days (a hospital episode recorded in the Scottish Morbidity Record associated with ICD10 codes I21 or I22, limited to position 1 or 2 on the discharge list)
From initial hospital discharge until 1 year following index presentation
Reattendance with suspected myocardial infarction at 30 days
Délai: From initial hospital discharge until 30 days following initial presentation.
A subsequent attendance to an Emergency Department or Acute Medical Unit during which a clinician responsible for care requests measurement of cardiac troponin for suspected acute coronary syndrome.
From initial hospital discharge until 30 days following initial presentation.
Reattendance with suspected myocardial infarction at 1 year
Délai: From initial hospital discharge until 1 year following initial presentation.
A subsequent attendance to an Emergency Department or Acute Medical Unit during which a clinician responsible for care requests measurement of cardiac troponin for suspected acute coronary syndrome.
From initial hospital discharge until 1 year following initial presentation.
Unscheduled coronary revascularisation at 30 days
Délai: From initial hospital discharge until 30 days following initial presentation
Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission.
From initial hospital discharge until 30 days following initial presentation
Unscheduled coronary revascularisation at 1 year
Délai: From initial hospital discharge until 1 year following initial presentation
Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission.
From initial hospital discharge until 1 year following initial presentation
Hospitalisation due to heart failure at 30 days
Délai: From discharge from the initial hospital attendance until 30 days from initial presentation
A hospital episode recorded in the Scottish Morbidity Record associated with ICD10 code I25.5 or I50, limited to position 1 or 2 on the discharge list.
From discharge from the initial hospital attendance until 30 days from initial presentation
Hospitalisation due to heart failure at 1 year
Délai: From discharge from the initial hospital attendance until 1 year from initial presentation
A hospital episode recorded in the Scottish Morbidity Record associated with ICD10 code I25.5 or I50, limited to position 1 or 2 on the discharge list.
From discharge from the initial hospital attendance until 1 year from initial presentation
Death at 30 days
Délai: From initial presentation until 30 days
Death due to any cause
From initial presentation until 30 days
Death at 1 year
Délai: From initial presentation until 1 year
Death due to any cause
From initial presentation until 1 year
Myocardial injury
Délai: From initial presentation to hospital until 24 hours after presentation.
Any cardiac troponin measurement above the sex-specific 99th percentile upper reference limit of the relevant assay, during the first 24 hours of the initial presentation to hospital.
From initial presentation to hospital until 24 hours after presentation.
Index myocardial infarction
Délai: From initial presentation until hospital discharge, up to 1 year
Myocardial infarction during the index presentation to hospital (ICD10 codes I21 or I22 associated with the episode in the Scottish Morbidity Record, restricted to position 1 or 2
From initial presentation until hospital discharge, up to 1 year
Coronary angiography within 30 days
Délai: From initial presentation until 30 days later
Invasive coronary angiography performed within 30 days of the initial presentation to hospital.
From initial presentation until 30 days later
Time until initial troponin test
Délai: From initial presentation to hospital until 24 hours after presentation.
Time from the arrival in the Emergency Department until collection of the first high-sensitivity cardiac troponin test.
From initial presentation to hospital until 24 hours after presentation.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Edinburgh

Collaborateurs

Roche Diagnostic Ltd.

Les enquêteurs

  • Chercheur principal: Andrew R Chapman, MD PhD, University of Edinburgh

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2026

Achèvement primaire (Estimé)

1 mai 2028

Achèvement de l'étude (Estimé)

1 mai 2029

Dates d'inscription aux études

Première soumission

22 mai 2026

Première soumission répondant aux critères de contrôle qualité

4 juin 2026

Première publication (Réel)

9 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AC25189

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

The individual data underlying the study can be made available via a Secure Data Environment to approved researchers on application to DataLoch (dataloch@ed.ac.uk)

Délai de partage IPD

From study conclusion for 5 years

Critères d'accès au partage IPD

Access is contingent on a project application to DataLoch that fulfils key governance criteria on independent review. Further details may be obtained by contacting dataloch@ed.ac.uk

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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