Sixth Generation High-sensitivity Cardiac Troponin T for the Early Rule Out of Myocardial Infarction: a Controlled Before and After Study (STEREO-MI)
4. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Typ studie
Intervenční
Zápis (Odhadovaný)
19500
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Andrew R Chapman, MD PhD
- Telefonní číslo: +44131 242 6200
- E-mail: a.r.chapman@ed.ac.uk
Studijní místa
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Midlothian
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Edinburgh, Midlothian, Spojené království, EH4 2XU
- Western General Hospital
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Kontakt:
- Andrew R Chapman, MD PhD
- Telefonní číslo: +44131 242 6200
- E-mail: a.r.chapman@ed.ac.uk
-
Vrchní vyšetřovatel:
- Andrew R Chapman, MD PhD
-
Edinburgh, Midlothian, Spojené království, EH16 4SA
- The Royal Infirmary of Edinburgh
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Kontakt:
- Andrew R Chapman, MD PhD
- Telefonní číslo: +44131 242 6200
- E-mail: a.r.chapman@ed.ac.uk
-
Vrchní vyšetřovatel:
- Andrew R Chapman, MD PhD
-
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West Lothian
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Livingston, West Lothian, Spojené království, EH54 6PP
- St. John's Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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.
Ostatní jména:
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Experimentální: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Length of stay within the Emergency Department
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Length of hospital stay
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Andrew R Chapman, MD PhD, University of Edinburgh
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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 Apr 22:e260477. doi: 10.1001/jamacardio.2026.0477. Online ahead of print.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. června 2026
Primární dokončení (Odhadovaný)
1. května 2028
Dokončení studie (Odhadovaný)
1. května 2029
Termíny zápisu do studia
První předloženo
22. května 2026
První předloženo, které splnilo kritéria kontroly kvality
4. června 2026
První zveřejněno (Aktuální)
9. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
9. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
4. června 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AC25189
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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)
Časový rámec sdílení IPD
From study conclusion for 5 years
Kritéria přístupu pro sdílení 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
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .