A Study of Population and Sex-specific Troponin Cutoffs for Ruling Out Acute Myocardial Infarction
NCT ID: NCT05336435
Last Updated: 2023-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
7500 participants
INTERVENTIONAL
2022-04-01
2025-02-28
Brief Summary
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The purpose of the DANSPOT study is to evaluate the clinical effect on diagnosis, treatment and outcomes in men and women presenting with acute MI of implementing international guidelines recommendations of sex-specific 99th percentile URLs for troponin into clinical practice.
First, to determine the sex-specific 99th percentile URLs of troponins based on a healthy Danish reference population, blood samples from Danish blood donors, were analyzed using one troponin T assay and four troponin I assays. Second, the DANSPOT study is a nationwide cluster-randomized trial with "stepped-wedge" design with participation of all 22 Danish hospital laboratories and associated departments of cardiology. With one-month intervals, each of 22 centers are randomized to shift from the presently applied uniform 99th percentile URL of troponin to our newly determined population and sex-specific 99th percentiles URLs. Each patient is followed in Danish registries for 12 months after first admission.
The hypothesis of the DANSPOT study is that implementation of population and sex-specific 99th URLs for troponin, will ensure that the right patients receive the right treatment. The investigators expect to detect significantly more women with acute MI, theoretically resulting in a more accurate diagnosis and treatment of women and men with acute MI.
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Detailed Description
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Coronary artery disease (CAD) is globally the leading cause of mortality for men and women. The latest consensus statement defines myocardial infarction as 1) a rise and/or fall in cardiac troponins with 2) at least one value above the 99th percentile upper reference limit (URL) in the context of 3) symptoms or clinical evidence of myocardial ischemia. Thus, levels of cardiac troponins play a key role in the diagnostic work-up in general. Currently, uniform manufacturer-provided URLs, defined by the 99th percentile of cardiac troponins in a healthy reference population, is applied in Danish hospitals as a diagnostic cut-off for acute MI for both men and women.
Lower levels of cardiac troponins are seen in healthy women as compared to healthy men, i.e. twice as high levels are seen in men. On this basis the clinical use of one uniform 99th percentile URL for cardiac troponins - i.e. applying the same diagnostic levels for men and women - may lead to a systematic under-diagnostication of acute MI in women and potentially an over-diagnostication of acute MI in men. Accordingly, the use of sex-specific 99th percentile URL of cardiac troponins are now recommended in recent guidelines by international cardiological societies, but this remains to be introduced in clinical practice.
The 99th percentile URLs for cardiac troponins currently used in Danish Hospitals are provided by the manufacturer of each specific assay based on blood samples from a healthy reference population collected by the manufacturer. Studies have shown that the 99th percentile value is dependent on patient sex as well as on the reference population selected and the definition for "healthy" used in these studies. It is well known that the 99th percentile URL should stem from a local reference population. This recommendation has never been implemented in Denmark.
The overall purpose of the study is to evaluate the clinical effect of implementing population and sex-specific 99th percentile URL for cardiac troponins in Denmark.
To determine the sex-specific 99th percentile URLs of troponins based on a healthy Danish reference population, blood samples from healthy Danish blood donors, were analyzed using one troponin T assay and four troponin I assays. Second, the DANSPOT study is a nationwide cluster-randomized trial with "stepped-wedge" design with participation of all 22 Danish hospital laboratories and associated departments of cardiology. With one-month intervals, each of 22 centers are randomized to shift from the presently applied uniform 99th percentile URL of troponin to our newly determined population and sex-specific 99th percentiles URLs. Each patient is followed in Danish registries for 12 months after first admission.
The clinical significance of sex-specific 99th percentile URLs of troponin is poorly investigated and for the same reason not yet implemented in Denmark or many other countries. The basic hypothesis of the DANSPOT study is that the implementation of population and sex-specific 99th URLs for troponin, will ensure that the right patients receive the right treatment. The investigators expect to detect significantly more women with acute MI, theoretically resulting in a more accurate diagnosis and treatment of women and men with acute MI. This would be guideline-defining for implementing sex-specific cutoffs for cardiac troponin in Denmark as well as internationally as recommended in guidelines by professional cardiological societies.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
SINGLE
Study Groups
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Control Arm - Current sex-uniform manufacturer provided 99th percentile URL of troponin
Standard use of the current sex-uniform manufacturer provided 99th percentile URL of troponin is utilized at Danish hospitals as a diagnostic cutoff for acute MI for both men and women
No interventions assigned to this group
Intervention Arm - New population and sex-specific 99th percentile URLs of troponin
Implementation of the new population and sex-specific 99th percentile URLs of troponin for the specific assay utilized at the enrolled centers.
Implementation of the new population and sex-specific 99th percentile URL for cardiac troponin
The new population and sex-specific 99th percentiles URLs will be implemented at all Danish hospitals receiving patients with chest pain for initial diagnostics for possible acute MI. This will take place as a randomized step-by-step introduction of population and sex-specific 99th percentile URLs for troponin in all hospital centers with a monthly start time interval. Each center is randomized to shifting from the sex-uniform manufacturer provided 99th percentile URL of cardiac troponin currently used nationwide to the new population and sex-specific 99th percentiles URLs provided by the DANSPOT study's first phase.
Interventions
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Implementation of the new population and sex-specific 99th percentile URL for cardiac troponin
The new population and sex-specific 99th percentiles URLs will be implemented at all Danish hospitals receiving patients with chest pain for initial diagnostics for possible acute MI. This will take place as a randomized step-by-step introduction of population and sex-specific 99th percentile URLs for troponin in all hospital centers with a monthly start time interval. Each center is randomized to shifting from the sex-uniform manufacturer provided 99th percentile URL of cardiac troponin currently used nationwide to the new population and sex-specific 99th percentiles URLs provided by the DANSPOT study's first phase.
Eligibility Criteria
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Inclusion Criteria
1. Presenting complaints suggestive of ACS
2. At least one cTn measurement within 24 hours of admission
3. A peak cTn value between the current sex-uniform manufacturer-derived 99th percentile URL and the novel sex-and population-specific 99th percentile URLs for women and men.
Presenting complaints suggestive of ACS will be identified in hospital records by the following presenting complaints of "chest pain" (DR074), "angina pectoris" (DI20) and "myocardial infarction" (DI21), "abdominal and pelvic pain" (DR10), "pain in the throat and chest" (DR07), "dyspnea" (DR060), "reflux" (DK21) and "observation due to suspicion of another cardiovascular disorder" (DZ035).
Study participants are included at their index admission, and subsequent admissions are evaluated in follow up analyses.
Exclusion Criteria
* Patients with discharge diagnoses with conditions like pericarditis, myocarditis, endocarditis, cardiomyopathy, valve disease, arrhythmia, heart failure, pulmonary embolism, digestive system diseases, diseases of the urinary and reproductive organs, and diseases of bones, muscles, and connective tissue, and no discharge diagnosis of myocardial infarction or angina pectoris
The initial month following the implementation of the new sex-specific 99th percentile URLs will be excluded from consideration, as it will be seen as an adjustment period. Consequently, the intervention period will be extended by one month.
18 Years
ALL
Yes
Sponsors
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Rigshospitalet, Denmark
OTHER
Nordsjaellands Hospital
OTHER
Amager Hospital
OTHER
Bispebjerg Hospital
OTHER
Zealand University Hospital
OTHER
Slagelse Sygehus
OTHER
Nykøbing Falster County Hospital
OTHER
Holbaek Sygehus
OTHER
Odense University Hospital
OTHER
Svendborg Hospital
OTHER
Kolding Sygehus
OTHER
Aarhus University Hospital
OTHER
Gødstrup Hospital
OTHER
Central Jutland Regional Hospital
OTHER
Randers Regional Hospital
OTHER
Glostrup University Hospital, Copenhagen
OTHER
Hvidovre University Hospital
OTHER
Vejle Hospital
OTHER
Hospital of Southern Jutland
OTHER
Horsens Hospital
OTHER
Aalborg University Hospital
OTHER
Regionshospital Nordjylland
OTHER_GOV
Sydvestjysk Sygehus
UNKNOWN
Herlev and Gentofte Hospital
OTHER
Herlev Hospital
OTHER
Responsible Party
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Kasper Iversen
Professor, Consultant, DMSc
Principal Investigators
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Kasper K Iversen, MD, DMsc
Role: PRINCIPAL_INVESTIGATOR
Herlev Hospital, University Hospital of Copenhagen
Locations
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Hospital of Southern Jutland
Aabenraa, , Denmark
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Bispebjerg & Frederiksberg Hospital
Bispebjerg, , Denmark
Rigshospitalet (Blegdamsvej)
Copenhagen Ø, , Denmark
Sydvestjysk Sygehus
Esbjerg, , Denmark
Glostrup University Hospital
Glostrup Municipality, , Denmark
Gødstrup Regional Hospital
Gødstrup, , Denmark
Herlev & Gentofte Hospital
Herlev, , Denmark
C Torp-Pedersen
Hillerød, , Denmark
North Denmark Regional Hospital
Hjørring, , Denmark
Holbaek Sygehus
Holbæk, , Denmark
Horsens Hospital
Horsens, , Denmark
Amager & Hvidovre Hospital
Hvidovre, , Denmark
Sygehus Lillebælt (Kolding Sygehus & Vejle Sygehus)
Kolding, , Denmark
Zealand University Hospital
Køge, , Denmark
Nykøbing Falster County Hospital
Nykøbing Falster, , Denmark
Odense University Hospital
Odense, , Denmark
Randers Regional Hospital
Randers, , Denmark
Slagelse Sygehus
Slagelse, , Denmark
Svendborg Hospital
Svendborg, , Denmark
Central Jutland Regional Hospital (Viborg Hospital & Silkeborg Hospital)
Viborg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Hasselbalch RB, Strandkjaer N, Kristensen J, Jorgensen N, Kock TO, Lange T, Ostrowski SR, Nissen J, Larsen MH, Vesterager Pedersen OB, Bor MV, Afzal S, Kamstrup PR, Dahl M, Hilsted L, Rode L, Jorgensen NR, Torp-Pedersen C, Bundgaard H, Iversen KK. Impact of age on cardiac troponin concentration among healthy individuals. Clin Biochem. 2025 Aug;138:110956. doi: 10.1016/j.clinbiochem.2025.110956. Epub 2025 Jun 11.
Strandkjaer N, Jorgensen N, Hasselbalch RB, Kristensen J, Knudsen MSS, Kock TO, Lange T, Lindholm MG, Bruun NE, Holmvang L, Terkelsen CJ, Pedersen CK, Christensen MK, Lassen JF, Hilsted L, Ladefoged S, Nybo M, Bor MV, Dahl M, Hansen AB, Kamstrup PR, Bundgaard H, Torp-Pedersen C, Iversen KK. DANSPOT: A Multicenter Stepped-Wedge Cluster-Randomized Trial of the Reclassification of Acute Myocardial Infarction: Rationale and Study Design. J Am Heart Assoc. 2024 May 7;13(9):e033493. doi: 10.1161/JAHA.123.033493. Epub 2024 Apr 19.
Other Identifiers
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FSP 20067240
Identifier Type: -
Identifier Source: org_study_id
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