Status:
UNKNOWN
A Study of Population and Sex-specific Troponin Cutoffs for Ruling Out Acute Myocardial Infarction
Lead Sponsor:
Herlev Hospital
Collaborating Sponsors:
Rigshospitalet, Denmark
Nordsjaellands Hospital
Conditions:
Coronary Syndrome, Acute
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
The present use of non-sex specific diagnostic cut-off levels of troponins in the diagnosis of acute myocardial infarction (MI) leads to under-diagnostication of acute MI in women and over-diagnostica...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
7500 Patients enrolled
Trial Details
Trial ID
NCT05336435
Start Date
April 1 2022
End Date
February 28 2025
Last Update
October 17 2023
Active Locations (22)
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1
Hospital of Southern Jutland
Aabenraa, Denmark, 6200
2
Aalborg University Hospital
Aalborg, Denmark, 9000
3
Aarhus University Hospital
Aarhus, Denmark, 8000
4
Bispebjerg & Frederiksberg Hospital
Bispebjerg, Denmark, 2400