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Heart attack diagnosis gets a Sex-Specific upgrade: new study could save Women's lives

NCT ID NCT05336435

Diagnosis Sponsor: Herlev Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This study looked at whether using different blood test cutoffs for men and women can better diagnose heart attacks. Current tests use the same cutoff for both sexes, which may miss heart attacks in women and over-diagnose them in men. Researchers tested new sex-specific cutoffs in over 4,800 patients across 22 Danish hospitals to see if this leads to more accurate diagnosis and better outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

5,175 people

The number who actually took part.

Started

Apr 2022

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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), "observation due to suspicion of myocardial infarction" (Z034), "myocardial infarction" (DI21), "abdominal and pelvic pain" (DR10), "pain in the throat and chest" (DR07), "dyspnea" (DR060), "reflux" (DK21), "ischemic heart disease" (DI22-DI25) 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, respiratory diseases, infectious diseases, digestive system diseases excluding reflux, digestive system diseases, diseases of the urinary and reproductive organs, and diseases of bones, muscles, and connective tissue, and do not have a 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.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome acute myocardial infarction coronary artery disorder intermediate coronary syndrome myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease Coronary syndrome, acute Myocardial infarction

Contacts and locations

Locations

  • Aalborg University Hospital

    Aalborg, 9000, Denmark

  • Aarhus University Hospital

    Aarhus, 8000, Denmark

  • Amager & Hvidovre Hospital

    Hvidovre, 2650, Denmark

  • Bispebjerg & Frederiksberg Hospital

    Bispebjerg, 2400, Denmark

  • C Torp-Pedersen

    Hillerød, 3400, Denmark

  • Central Jutland Regional Hospital (Viborg Hospital & Silkeborg Hospital)

    Viborg, 8800, Denmark

  • Glostrup University Hospital

    Glostrup Municipality, 2600, Denmark

  • Gødstrup Regional Hospital

    Gødstrup, 7400, Denmark

  • Herlev & Gentofte Hospital

    Herlev, 2730, Denmark

  • Holbaek Sygehus

    Holbæk, 4300, Denmark

  • Horsens Hospital

    Horsens, 8700, Denmark

  • Hospital of Southern Jutland

    Aabenraa, 6200, Denmark

  • North Denmark Regional Hospital

    Hjørring, 9800, Denmark

  • Nykøbing Falster County Hospital

    Nykøbing Falster, 4800, Denmark

  • Odense University Hospital

    Odense, 5000, Denmark

  • Randers Regional Hospital

    Randers, 8930, Denmark

  • Rigshospitalet (Blegdamsvej)

    Copenhagen Ø, 2100, Denmark

  • Slagelse Sygehus

    Slagelse, 4200, Denmark

  • Svendborg Hospital

    Svendborg, 5700, Denmark

  • Sydvestjysk Sygehus

    Esbjerg, 6700, Denmark

  • Sygehus Lillebælt (Kolding Sygehus & Vejle Sygehus)

    Kolding, 6000, Denmark

  • Zealand University Hospital

    Køge, 4600, Denmark

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