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Implementing the 6th Generation Cardiac Troponin T

10 november 2026 uppdaterad av: Rasmus Bo Hasselbalch

Implementing the 6th Generation Cardiac Troponin T: A Stepped Wedged Cluster-randomized Trial

This study will test how a new blood test for troponin T can be introduced into routine hospital care in Denmark and Norway. The study will look at whether the new test helps doctors assess and treat patients with possible heart problems more effectively and safely.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Background Cardiac troponin (cTn) is the key biomarker for diagnosing myocardial infarction (MI). There are two cardiac specific isoforms of cTn, cTnT and cTnI, considered equal in contemporary guidelines. About half of hospitals in Denmark and two thirds of Norwegian providing acute cardiovascular care use cTnT from Roche Diagnostics in routine practice. An improved version of this assay has recently been developed, named the 6th generation cTnT. This novel assay expected to be implemented worldwide within the next years, but there is still limited data comparing it with the previous generation of cTnT. We aim to implement and test the use of the new 6th generation cTnT assay in Danish-Norwegian collaborative, stepped-wedge trial.

Methods This will be a stepped-wedged cluster-randomized implementation study investigating the medical and practical real-life consequences of switching from the 5th to the 6th generation cTnT assay in routine use. All hospitals using cTnT in either Denmark or Norway will be invited to participate in the study. Centers will be randomized to an implementation date. The hospital should switch assay within 1-15 days after the applicable deadline. Following admission, patients will be followed through national registries.

Assay specifics The 6th generation cTnT assay is expected to have a limit of quantification at 1.5 ng/L and an analyti-cal variation of 3% at the 99th upper reference limit. All sites will use the reference values estimated in the assay insert.

Timeline There will be 7 centers in Denmark and 4 centers in Norway in the study. Data collection will begin on the 1st of August 2026 with the first centers expected to switch on the 1st of October 2026. This will mean that the final center will switch on the 1st of August 2027, and the primary results will be available by the end of March 2028. Each laboratory will receive a plan for local analytical verification of the assay.

Collaboration The study is designed and performed as a collaborative effort between Danish and Norwegian re-searchers and led by Kristin Aakre, Rasmus Bo Hasselbalch, Torbjørn Omland and Kasper Iversen. All centers will be invited to participate and contributors fulfilling Vancouver criteria will be invited as authors of any publications. This implementation study will be performed in collaboration with the national societies of clinical biochemistry.

Ethics The project has been presented to the Danish regional ethics committee and is expected to receive a waiver for patient consent in this study. A similar ethical waiver has been given in Norway. The data will follow GDPR guidelines regarding data protection.

Power calculations In a stepped wedge design the period between successive interventions (i.e. stops) is the main design parameter. The study is designed as a primary superiority trial. Given 11 centers and an ex-pected event rate of about 4% and each center including between 200 and 800 patients a month, the study would have above 90% power to show an absolute risk difference of 0.8%. This calcula-tion was performed in collaboration with Professor Theis Lange.

Studietyp

Interventionell

Inskrivning (Beräknad)

22600

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Danmark
      • Herlev, Danmark, 2730
        • Har inte rekryterat ännu
        • Copenhagen University Hospital - Herlev and Gentofte Hospital
        • Kontakt:
      • Horsens, Danmark, 8700
      • Kolding, Danmark, 6000
      • København NV, Danmark, 2400
        • Har inte rekryterat ännu
        • Copenhagen University Hospital - Bispebjerg
        • Kontakt:
      • København Ø, Danmark, 2100
        • Har inte rekryterat ännu
        • Copenhagen University Hospital - Rigshospitalet
        • Kontakt:
      • Odense, Danmark, 5000
      • Svendborg, Danmark, 5700
        • Har inte rekryterat ännu
        • Odense Universitetshospital Svendborg Sygehus
        • Kontakt:
      • Sønderborg, Danmark, 6400
  • Norge

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Admitted at any of the participating hospitals
  • At least one measurement of cardiac troponin T as a part of routine care in the ED

Exclusion Criteria:

  • Readmission within the study followup

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 5th generation cardiac troponin T arm

Treatment is based on the use of the 5th generation troponin T assay
Diagnostiskt test: Standard arm (5th generation of troponin T)

Regular use of the 5th generation troponin T assay
Experimentell: 6th generation cardiac troponin T arm

Treatment is based on the use of the new 6th generation troponin T assay
Diagnostiskt test: Use of the 6th generation of cardiac troponin T assay

The change will be in a stepped-wedge cluster randomised design

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Composite endpoint of death from any cause and MI, or revascularization within 6 months after admission (PCI and CABG).
Tidsram: 6 months

This will exclude events during the index admission
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The incidence of fatal and non-fatal MI (I21, I22)
Tidsram: At the time of hospital discharge (Day 0)

All events during admission
At the time of hospital discharge (Day 0)
Unstable angina pectoris (I20.0)
Tidsram: At the time of hospital discharge (Day 0)

Unstable angina diagnosed during admission
At the time of hospital discharge (Day 0)
Invasive coronary angiography
Tidsram: Up to 30 days following discharge

Use of invasive coronary angiography during admission, or planned under index admission
Up to 30 days following discharge
Coronary CT angiography
Tidsram: Up to 30 days following discharge

Use of coronary CT angiography during admission or planned at index admission
Up to 30 days following discharge
The length of stay
Tidsram: At the time of hospital discharge (Day 0)

The length of stay during index admission
At the time of hospital discharge (Day 0)
Readmissions within 30 days
Tidsram: Within 30 days of index admission

The rate of readmission following index admission within 30 days for any cardiovascular cause
Within 30 days of index admission

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage discharged from the hospital within 6 hours
Tidsram: At the time of hospital discharge (Day 0)

Percentage discharged from the hospital within 6 hours (if data can be made available)
At the time of hospital discharge (Day 0)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Rasmus Bo Hasselbalch

Samarbetspartners

University of Bergen
Haukeland University Hospital

Utredare

  • Huvudutredare: Kristin Aakre, MD, PhD, Haukeland University Hospital
  • Huvudutredare: Kasper Iversen, MD, Dmsc, Copenhagen University Hospital - Herlev and Gentofte Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 augusti 2026

Primärt slutförande (Beräknad)

31 mars 2028

Avslutad studie (Beräknad)

31 juli 2028

Studieregistreringsdatum

Först inskickad

4 november 2026

Först inskickad som uppfyllde QC-kriterierna

10 november 2026

Första postat (Faktisk)

13 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • F-26025642

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Due to restrictions within Danish and Norwegian law for registry data

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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