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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 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

19500

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Zjednoczone Królestwo
    • Midlothian
      • Edinburgh, Midlothian, Zjednoczone Królestwo, EH4 2XU
        • Rekrutacyjny
        • Western General Hospital
        • Kontakt:
        • Główny śledczy:
          • Andrew R Chapman, MD PhD
      • Edinburgh, Midlothian, Zjednoczone Królestwo, EH16 4SA
        • Rekrutacyjny
        • The Royal Infirmary of Edinburgh
        • Kontakt:
        • Główny śledczy:
          • Andrew R Chapman, MD PhD
    • West Lothian
      • Livingston, West Lothian, Zjednoczone Królestwo, EH54 6PP
        • Rekrutacyjny
        • St. John's Hospital
        • Kontakt:
        • Główny śledczy:
          • Andrew R Chapman, MD PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Diagnostyczny
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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 diagnostyczny: 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.
Inne nazwy:
  • Troponin T gen 5
Eksperymentalny: 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 diagnostyczny: 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.
Inne nazwy:
  • Troponin T high sensitivity generation six
  • TnT hs Gen 6

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Length of stay within the Emergency Department
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Length of hospital stay
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: From initial presentation until 30 days
Death due to any cause
From initial presentation until 30 days
Death at 1 year
Ramy czasowe: From initial presentation until 1 year
Death due to any cause
From initial presentation until 1 year
Myocardial injury
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Edinburgh

Współpracownicy

Roche Diagnostic Ltd.

Śledczy

  • Główny śledczy: Andrew R Chapman, MD PhD, University of Edinburgh

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 maja 2028

Ukończenie studiów (Szacowany)

1 maja 2029

Daty rejestracji na studia

Pierwszy przesłany

22 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

9 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • AC25189

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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)

Ramy czasowe udostępniania IPD

From study conclusion for 5 years

Kryteria dostępu do udostępniania 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 informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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