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Evaluating sex-specific troponin levels for diagnosing heart attacks

A Randomized Clinical Trial (RCT) of Population and Sex-specific Troponin Cutoffs for Ruling Out Acute Myocardial Infarction - The Danish Study of Population and Sex-Specific Cutoffs of Troponin

Not applicable Interventional Herlev Hospital · NCT05336435

This study is testing if using different troponin level cut-offs for men and women can help doctors better diagnose heart attacks in people showing symptoms.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment7500 (estimated)
Ages18 Years and up
SexAll
SponsorHerlev Hospital Academic / other
Locations22 sites (Aabenraa and 21 other locations)
Trial IDNCT05336435 on ClinicalTrials.gov

What this trial studies

This study aims to assess the impact of implementing sex-specific 99th percentile cut-off levels for cardiac troponin in diagnosing acute myocardial infarction (MI). Currently, a uniform cut-off is used for both men and women, which may lead to under-diagnosis in women and over-diagnosis in men. By documenting the clinical effects of these new cut-offs through a randomized nationwide implementation, the study seeks to improve diagnostic accuracy and patient outcomes. Participants will include men and women presenting with symptoms suggestive of acute coronary syndrome and specific troponin measurements.

Who should consider this trial

Good fit: Ideal candidates are men and women presenting with symptoms suggestive of acute coronary syndrome and having troponin measurements within specified ranges.

Not a fit: Patients who do not present with symptoms of acute coronary syndrome or do not have troponin measurements will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses of acute myocardial infarction, particularly in women, improving treatment and outcomes.

How similar studies have performed: Other studies have indicated that using sex-specific cut-offs for biomarkers can improve diagnostic accuracy, suggesting this approach may be beneficial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria for the primary cohort:

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

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:

* 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.

Where this trial is running

Aabenraa and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Syndrome, AcuteCoronary Artery DiseaseMyocardial Infarctioncoronary syndromemyocardial infarctionclinical assessmentbiomarkertroponin
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.