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 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
19500
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Andrew R Chapman, MD PhD
- Telefonnummer: +44131 242 6200
- E-Mail: a.r.chapman@ed.ac.uk
Studienorte
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Midlothian
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Edinburgh, Midlothian, Vereinigtes Königreich, EH4 2XU
- Western General Hospital
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Kontakt:
- Andrew R Chapman, MD PhD
- Telefonnummer: +44131 242 6200
- E-Mail: a.r.chapman@ed.ac.uk
-
Hauptermittler:
- Andrew R Chapman, MD PhD
-
Edinburgh, Midlothian, Vereinigtes Königreich, EH16 4SA
- The Royal Infirmary of Edinburgh
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Kontakt:
- Andrew R Chapman, MD PhD
- Telefonnummer: +44131 242 6200
- E-Mail: a.r.chapman@ed.ac.uk
-
Hauptermittler:
- Andrew R Chapman, MD PhD
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West Lothian
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Livingston, West Lothian, Vereinigtes Königreich, EH54 6PP
- St. John's Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver 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
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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.
Andere Namen:
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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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Length of stay within the Emergency Department
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Length of hospital stay
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Andrew R Chapman, MD PhD, University of Edinburgh
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juni 2026
Primärer Abschluss (Geschätzt)
1. Mai 2028
Studienabschluss (Geschätzt)
1. Mai 2029
Studienanmeldedaten
Zuerst eingereicht
22. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. Juni 2026
Zuerst gepostet (Tatsächlich)
9. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. Juni 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- AC25189
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
From study conclusion for 5 years
IPD-Sharing-Zugriffskriterien
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
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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