Clinical Research Directory

A Study of Population and Sex-specific Troponin Cutoffs for Ruling Out Acute Myocardial Infarction

Sponsor: Herlev Hospital

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 utilised 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 analysed using one troponin T assay and four troponin I assays. Second, the DANSPOT study is a nationwide cluster-randomised trial with a "stepped-wedge" design, with participation of all 22 Danish hospital laboratories and associated departments of cardiology. With one-month intervals, each of the 22 centres is randomised to shift from the presently applied uniform 99th percentile URL of troponin to our newly determined population- and sex-specific 99th percentile URL. Each patient is followed up for 12 months after their first troponin measurement during the index admission. The hypothesis of the DANSPOT study is that implementation of population- and sex-specific 99th percentile 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.

Official title: A Randomised 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

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