NCT05336435

Brief Summary

Acute myocardial infarction (MI) is defined as a rise and/or fall in cardiac troponins (cTn) with at least one value above the 99th percentile upper reference limit (URL) in the context of symptoms or clinical evidence of myocardial ischemia. The URL is based on measurements in a healthy reference population. Currently, a 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. Reportedly, healthy men have twofold the troponin level compared to healthy women, suggesting that the use of a uniform URL for troponins may lead to the under-diagnostication of acute MI in women and potentially over-diagnostication in men. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

22 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

2.9 years

First QC Date

March 29, 2022

Last Update Submit

October 16, 2023

Conditions

Coronary Syndrome, AcuteCoronary Artery DiseaseMyocardial Infarction

Keywords

coronary syndromemyocardial infarctionclinical assessmentbiomarkertroponin

Outcome Measures

Primary Outcomes (1)

  • A composite of myocardial infarction, unplanned revascularisation (after index admission) or all cause mortality within 1 year of first admission for the primary cohort.

    Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. Primary cohort is defined as the cohort of women and men with suspected acute coronary syndrome (ACS) with at least two cTn measurements within 24 hours with a maximal cTn level between the current sex-uniform manufacturer-derived 99th percentiles of cTn and the newly defined sex-specific 99th percentiles for women and men.

    12 months after index admission

Secondary Outcomes (42)

  • Number of women with coronary events in the primary cohort (after index admission)

    12 months after index admission

  • Number of men with coronary events in the primary cohort (after index admission)

    12 months after index admission

  • Number of women and men with coronary events in the primary cohort (after index admission)

    12 months after index admission

  • Number of women diagnosed with acute MI (after index admission)

    12 months after index admission

  • Number of women diagnosed with acute MI

    12 months from index admission

  • +37 more secondary outcomes

Study Arms (2)

Control Arm - Current sex-uniform manufacturer provided 99th percentile URL of troponin

NO INTERVENTION

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

Intervention Arm - New population and sex-specific 99th percentile URLs of troponin

ACTIVE COMPARATOR

Implementation of the new population and sex-specific 99th percentile URLs of troponin for the specific assay utilized at the enrolled centers.

Diagnostic Test: Implementation of the new population and sex-specific 99th percentile URL for cardiac troponin

Interventions

Implementation of the new population and sex-specific 99th percentile URL for cardiac troponinDIAGNOSTIC_TEST

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.

Intervention Arm - New population and sex-specific 99th percentile URLs of troponin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The primary cohort will include the women and men who are expected to be most significantly impacted by the intervention, and this group is specifically defined by
  • Presenting complaints suggestive of ACS
  • At least one cTn measurement within 24 hours of admission
  • 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.

You may not qualify if:

  • Age \< 18 years
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Hospital of Southern Jutland

Aabenraa, 6200, Denmark

RECRUITING

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

Bispebjerg & Frederiksberg Hospital

Bispebjerg, 2400, Denmark

NOT YET RECRUITING

Rigshospitalet (Blegdamsvej)

Copenhagen Ø, 2100, Denmark

RECRUITING

Sydvestjysk Sygehus

Esbjerg, 6700, Denmark

NOT YET RECRUITING

Glostrup University Hospital

Glostrup Municipality, 2600, Denmark

RECRUITING

Gødstrup Regional Hospital

Gødstrup, 7400, Denmark

RECRUITING

Herlev & Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

C Torp-Pedersen

Hillerød, 3400, Denmark

RECRUITING

North Denmark Regional Hospital

Hjørring, 9800, Denmark

RECRUITING

Holbaek Sygehus

Holbæk, 4300, Denmark

NOT YET RECRUITING

Horsens Hospital

Horsens, 8700, Denmark

RECRUITING

Amager & Hvidovre Hospital

Hvidovre, 2650, Denmark

NOT YET RECRUITING

Sygehus Lillebælt (Kolding Sygehus & Vejle Sygehus)

Kolding, 6000, Denmark

NOT YET RECRUITING

Zealand University Hospital

Køge, 4600, Denmark

NOT YET RECRUITING

Nykøbing Falster County Hospital

Nykøbing Falster, 4800, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Randers Regional Hospital

Randers, 8930, Denmark

NOT YET RECRUITING

Slagelse Sygehus

Slagelse, 4200, Denmark

NOT YET RECRUITING

Svendborg Hospital

Svendborg, 5700, Denmark

RECRUITING

Central Jutland Regional Hospital (Viborg Hospital & Silkeborg Hospital)

Viborg, 8800, Denmark

NOT YET RECRUITING

Related Publications (2)

  • 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.

    PMID: 40513714DERIVED

  • 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.

    PMID: 38639348DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeCoronary Artery DiseaseMyocardial InfarctionAngina, Unstable

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Kasper K Iversen, MD, DMsc

    Herlev Hospital, University Hospital of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kasper K Iversen, MD, DMsc

CONTACT

38686009Kasper.Karmark.Iversen@regionh.dk

Christian Torp-Pedersen, MD, DMsc

CONTACT

christian.torp-pedersen.01@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A diagnosis of acute MI will be adjudicated for all individuals in the primary cohort by an endpoint committee consisting of three cardiologists from another region in Denmark.
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: A nationwide cluster-randomized trial with "stepped-wedge" design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Consultant, DMSc

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 20, 2022

Study Start

April 1, 2022

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations

DK(22)