Sixth Generation High-sensitivity Cardiac Troponin T for the Early Rule Out of Myocardial Infarction: a Controlled Before and After Study (STEREO-MI)
6 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
19500
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Andrew R Chapman, MD PhD
- Número de teléfono: +44131 242 6200
- Correo electrónico: a.r.chapman@ed.ac.uk
Ubicaciones de estudio
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Midlothian
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Edinburgh, Midlothian, Reino Unido, EH4 2XU
- Reclutamiento
- Western General Hospital
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Contacto:
- Andrew R Chapman, MD PhD
- Número de teléfono: +44131 242 6200
- Correo electrónico: a.r.chapman@ed.ac.uk
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Investigador principal:
- Andrew R Chapman, MD PhD
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Edinburgh, Midlothian, Reino Unido, EH16 4SA
- Reclutamiento
- The Royal Infirmary of Edinburgh
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Contacto:
- Andrew R Chapman, MD PhD
- Número de teléfono: +44131 242 6200
- Correo electrónico: a.r.chapman@ed.ac.uk
-
Investigador principal:
- Andrew R Chapman, MD PhD
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West Lothian
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Livingston, West Lothian, Reino Unido, EH54 6PP
- Reclutamiento
- St. John's Hospital
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Contacto:
- Andrew R Chapman, MD PhD
- Número de teléfono: +44131 242 6200
- Correo electrónico: a.r.chapman@ed.ac.uk
-
Investigador principal:
- Andrew R Chapman, MD PhD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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
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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.
Otros nombres:
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Experimental: 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
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Length of stay within the Emergency Department
Periodo de tiempo: From Emergency Department arrival until Emergency Department discharge or hospital admission, up to 7 days
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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.
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From Emergency Department arrival until Emergency Department discharge or hospital admission, up to 7 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Length of hospital stay
Periodo de tiempo: From initial presentation until hospital discharge, up to 1 year
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Total length of hospital stay from presentation until discharge from hospital
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From initial presentation until hospital discharge, up to 1 year
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Hospital admission
Periodo de tiempo: From initial presentation to the Emergency Department up to 7 days
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Admission to hospital during index presentation
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From initial presentation to the Emergency Department up to 7 days
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Serial cardiac troponin measurements
Periodo de tiempo: From initial presentation until hospital discharge, up to 1 year
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Number of serial cardiac troponin measurements during index admission
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From initial presentation until hospital discharge, up to 1 year
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Cardiovascular death at 30 days
Periodo de tiempo: From initial presentation until 30 days after initial presentation
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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)
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From initial presentation until 30 days after initial presentation
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Cardiovascular death at 1 year
Periodo de tiempo: From initial presentation until 1 year after initial presentation
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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)
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From initial presentation until 1 year after initial presentation
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Myocardial infarction after discharge at 30 days
Periodo de tiempo: From initial hospital discharge until 30 days following index presentation
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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)
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From initial hospital discharge until 30 days following index presentation
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Myocardial infarction after discharge at 1 year
Periodo de tiempo: From initial hospital discharge until 1 year following index presentation
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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)
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From initial hospital discharge until 1 year following index presentation
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Reattendance with suspected myocardial infarction at 30 days
Periodo de tiempo: From initial hospital discharge until 30 days following initial presentation.
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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.
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From initial hospital discharge until 30 days following initial presentation.
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Reattendance with suspected myocardial infarction at 1 year
Periodo de tiempo: From initial hospital discharge until 1 year following initial presentation.
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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.
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From initial hospital discharge until 1 year following initial presentation.
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Unscheduled coronary revascularisation at 30 days
Periodo de tiempo: From initial hospital discharge until 30 days following initial presentation
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Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission.
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From initial hospital discharge until 30 days following initial presentation
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Unscheduled coronary revascularisation at 1 year
Periodo de tiempo: From initial hospital discharge until 1 year following initial presentation
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Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission.
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From initial hospital discharge until 1 year following initial presentation
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Hospitalisation due to heart failure at 30 days
Periodo de tiempo: From discharge from the initial hospital attendance until 30 days from initial presentation
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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.
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From discharge from the initial hospital attendance until 30 days from initial presentation
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Hospitalisation due to heart failure at 1 year
Periodo de tiempo: From discharge from the initial hospital attendance until 1 year from initial presentation
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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.
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From discharge from the initial hospital attendance until 1 year from initial presentation
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Death at 30 days
Periodo de tiempo: From initial presentation until 30 days
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Death due to any cause
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From initial presentation until 30 days
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Death at 1 year
Periodo de tiempo: From initial presentation until 1 year
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Death due to any cause
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From initial presentation until 1 year
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Myocardial injury
Periodo de tiempo: From initial presentation to hospital until 24 hours after presentation.
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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.
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From initial presentation to hospital until 24 hours after presentation.
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Index myocardial infarction
Periodo de tiempo: From initial presentation until hospital discharge, up to 1 year
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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
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From initial presentation until hospital discharge, up to 1 year
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Coronary angiography within 30 days
Periodo de tiempo: From initial presentation until 30 days later
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Invasive coronary angiography performed within 30 days of the initial presentation to hospital.
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From initial presentation until 30 days later
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Time until initial troponin test
Periodo de tiempo: From initial presentation to hospital until 24 hours after presentation.
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Time from the arrival in the Emergency Department until collection of the first high-sensitivity cardiac troponin test.
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From initial presentation to hospital until 24 hours after presentation.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Andrew R Chapman, MD PhD, University of Edinburgh
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Boeddinghaus J, Li Z, Bularga A, Taggart C, Wereski R, Chapman AR, Lee KK, Tuck C, Gunn R, Jenks S, McCance K, Pattenden R, Malo J, Thurston AJF, Tew YY, McDermott M, Gray A, Cruden NLM, Anand A, Kimenai DM, Mills NL; TWITCH-ED Investigators. Clinical Decisions and Outcomes After Switching High-Sensitivity Cardiac Troponin Assays in Suspected ACS: An Interrupted Time-Series Study. JAMA Cardiol. 2026 Feb 1;11(2):186-192. doi: 10.1001/jamacardio.2025.4661.
- Thurston AJF, Tew YY, Lopez-Ayala P, Koechlin L, O'Brien R, Lynch S, Cooper JG, Fujisawa T, Bima P, McDermott M, Tuck C, Mizerska M, Highton-Williamson E, McCurrach F, Lowry MTH, Doudesis D, Anand A, Lee KK, Ferry AV, Chapman A, Newby DE, Boeddinghaus J, Mueller C, Gray AJ, Mills NL; POC-ET and APACE Investigators. Early Rule Out of Myocardial Infarction With a Novel High-Sensitivity Cardiac Troponin T Assay. JAMA Cardiol. 2026 Jun 1;11(6):583-592. doi: 10.1001/jamacardio.2026.0477.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2026
Finalización primaria (Estimado)
1 de mayo de 2028
Finalización del estudio (Estimado)
1 de mayo de 2029
Fechas de registro del estudio
Enviado por primera vez
22 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de junio de 2026
Publicado por primera vez (Actual)
9 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AC25189
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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)
Marco de tiempo para compartir IPD
From study conclusion for 5 years
Criterios de acceso compartido de 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
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .