An interventional study of Use of the 6th generation of cardiac troponin T assay and Standard arm (5th generation of troponin T) in MI(Myocardial Infarction) and ACS (Acute Coronary Syndrome), sponsored by Rasmus Bo Hasselbalch. Recruiting at 22 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Rasmus Bo Hasselbalch · Not applicable, Interventional, and Diagnostic
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Among 66 studies in Myocardial Infarction with a site in Norway — 6 open to participants now, 10 under way, 3 of them phase 3. Myocardial Infarction · Norway.
Among the 66 studies in Myocardial Infarction with a site in Norway, this one is the 2nd largest by planned enrollment of the 47 interventional ones that give a count, is one of 3 that started in 2026, is one of 19 with no phase, and was the 66th registered.
2,272 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
Browse Myocardial Infarction studies →6 of the 66 studies in Myocardial Infarction with a site in Norway are open now. Recruiting first, the newest first:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Sites in Norway, Ireland, Latvia and 2 more countries
Ages 18+
Oslo University Hospital · Sites in Norway
Ages 18+
CSL Behring · Sites in Norway, United States, Argentina and 32 more countries
Ages 18+
Oslo University Hospital · Sites in Norway
Ages 18+
Viatris Innovation GmbH · Sites in Norway, United States, Australia and 44 more countries
Ages 18+
A study can be open while its sites in Norway have not opened yet or have stopped. Only those recruiting at a site in Norway →
Of the 255 Myocardial Infarction studies recruiting now, 172 (67%) set no upper age limit and 26 (10%) stop at 75 or younger; 16 take children under 18; 27 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
66 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 5 · Phase 3 16 · Phase 4 8
First in 1995; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 22,600 is above the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Median enrollment 1,027 across the 47 interventional studies, 871 across the 19 observational. Of the 49 that completed or were terminated, 9 (18%) have results posted.
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21 of 66 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Rasmus Bo Hasselbalch as lead sponsor.
Rasmus Bo Hasselbalch has 1 study filed under Myocardial Infarction — fewer than ten, so there is no comparison to draw.
1 of the studies in Myocardial Infarction with a site in Norway that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04957719Phase 3Viatris Innovation GmbHSelatogrel Outcome Study in Suspected Acute Myocardial Infarction | 2027-07 |
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Among the 66 studies in Myocardial Infarction with a site in Norway, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Treatment is based on the use of the 5th generation troponin T assay
Diagnostic Test: Standard arm (5th generation of troponin T)
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
Regular use of the 5th generation troponin T assay
Composite endpoint of death from any cause and MI, or revascularization within 6 months after admission (PCI and CABG).
This will exclude events during the index admission
Time frame: 6 months
The incidence of fatal and non-fatal MI (I21, I22)
All events during admission
Time frame: At the time of hospital discharge (Day 0)
Unstable angina pectoris (I20.0)
Unstable angina diagnosed during admission
Time frame: At the time of hospital discharge (Day 0)
Invasive coronary angiography
Use of invasive coronary angiography during admission, or planned under index admission
Time frame: Up to 30 days following discharge
Coronary CT angiography
Use of coronary CT angiography during admission or planned at index admission
Time frame: Up to 30 days following discharge
The length of stay
The length of stay during index admission
Time frame: At the time of hospital discharge (Day 0)
Readmissions within 30 days
The rate of readmission following index admission within 30 days for any cardiovascular cause
Time frame: Within 30 days of index admission
Percentage discharged from the hospital within 6 hours
Percentage discharged from the hospital within 6 hours (if data can be made available)
Time frame: At the time of hospital discharge (Day 0)
Plan to share: No — Due to restrictions within Danish and Norwegian law for registry data
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Mar 2028, 19 months after the start.
Of 321 non-industry interventional studies with no phase under Myocardial Infarction, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's planned 19 months is below that.
Counting every sponsor, half of 354 studies reached it within 34 months; a quarter within 15 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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