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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)

4. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

19500

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Det Forenede Kongerige
    • Midlothian
      • Edinburgh, Midlothian, Det Forenede Kongerige, EH4 2XU
        • Western General Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Andrew R Chapman, MD PhD
      • Edinburgh, Midlothian, Det Forenede Kongerige, EH16 4SA
        • The Royal Infirmary of Edinburgh
        • Kontakt:
        • Ledende efterforsker:
          • Andrew R Chapman, MD PhD
    • West Lothian
      • Livingston, West Lothian, Det Forenede Kongerige, EH54 6PP
        • St. John's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv 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
Diagnostisk test: 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.
Andre navne:
  • Troponin T gen 5
Eksperimentel: 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
Diagnostisk test: 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.
Andre navne:
  • Troponin T high sensitivity generation six
  • TnT hs Gen 6

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Length of stay within the Emergency Department
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Length of hospital stay
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From initial presentation until 30 days
Death due to any cause
From initial presentation until 30 days
Death at 1 year
Tidsramme: From initial presentation until 1 year
Death due to any cause
From initial presentation until 1 year
Myocardial injury
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Edinburgh

Samarbejdspartnere

Roche Diagnostic Ltd.

Efterforskere

  • Ledende efterforsker: Andrew R Chapman, MD PhD, University of Edinburgh

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2029

Datoer for studieregistrering

Først indsendt

22. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AC25189

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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)

IPD-delingstidsramme

From study conclusion for 5 years

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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