Implementing the 6th Generation Cardiac Troponin T

November 10, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

22600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 5th generation cardiac troponin T arm

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

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

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint of death from any cause and MI, or revascularization within 6 months after admission (PCI and CABG).
Time Frame: 6 months

This will exclude events during the index admission
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of fatal and non-fatal MI (I21, I22)
Time Frame: 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)
Time Frame: At the time of hospital discharge (Day 0)

Unstable angina diagnosed during admission
At the time of hospital discharge (Day 0)
Invasive coronary angiography
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage discharged from the hospital within 6 hours
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rasmus Bo Hasselbalch

Collaborators

University of Bergen
Haukeland University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

November 4, 2026

First Submitted That Met QC Criteria

November 10, 2026

First Posted (Actual)

November 13, 2026

Study Record Updates

Last Update Posted (Actual)

November 13, 2026

Last Update Submitted That Met QC Criteria

November 10, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-26025642

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to restrictions within Danish and Norwegian law for registry data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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