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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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.

Locations
Other Locations
Denmark
Hospital of Southern Jutland
RECRUITING
Aabenraa
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Bispebjerg & Frederiksberg Hospital
NOT_YET_RECRUITING
Bispebjerg
Rigshospitalet (Blegdamsvej)
RECRUITING
Copenhagen Ø
Sydvestjysk Sygehus
NOT_YET_RECRUITING
Esbjerg
Glostrup University Hospital
RECRUITING
Glostrup Municipality
Gødstrup Regional Hospital
RECRUITING
Gødstrup
Herlev & Gentofte Hospital
RECRUITING
Herlev
C Torp-Pedersen
RECRUITING
Hillerød
North Denmark Regional Hospital
RECRUITING
Hjørring
Holbaek Sygehus
NOT_YET_RECRUITING
Holbæk
Horsens Hospital
RECRUITING
Horsens
Amager & Hvidovre Hospital
NOT_YET_RECRUITING
Hvidovre
Zealand University Hospital
NOT_YET_RECRUITING
Køge
Sygehus Lillebælt (Kolding Sygehus & Vejle Sygehus)
NOT_YET_RECRUITING
Kolding
Nykøbing Falster County Hospital
RECRUITING
Nykøbing Falster
Odense University Hospital
RECRUITING
Odense
Randers Regional Hospital
NOT_YET_RECRUITING
Randers
Slagelse Sygehus
NOT_YET_RECRUITING
Slagelse
Svendborg Hospital
RECRUITING
Svendborg
Central Jutland Regional Hospital (Viborg Hospital & Silkeborg Hospital)
NOT_YET_RECRUITING
Viborg
Contact Information
Primary
Kasper K Iversen, MD, DMsc
Kasper.Karmark.Iversen@regionh.dk
38686009
Backup
Christian Torp-Pedersen, MD, DMsc
christian.torp-pedersen.01@regionh.dk
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 7500
Treatments
No_intervention: Control Arm - Current sex-uniform manufacturer provided 99th percentile URL of troponin
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
Active_comparator: Intervention Arm - New population and sex-specific 99th percentile URLs of troponin
Implementation of the new population and sex-specific 99th percentile URLs of troponin for the specific assay utilized at the enrolled centers.
Sponsors
Collaborators: Rigshospitalet, Denmark, Bispebjerg Hospital, Glostrup University Hospital, Copenhagen, Kolding Sygehus, Zealand University Hospital, Odense University Hospital, Randers Regional Hospital, Slagelse Sygehus, Vejle Hospital, Aarhus University Hospital, Nykøbing Falster County Hospital, Central Jutland Regional Hospital, Gødstrup Hospital, Nordsjaellands Hospital, Svendborg Hospital, Herlev and Gentofte Hospital, Hospital of Southern Jutland, Horsens Hospital, Aalborg University Hospital, Sydvestjysk Sygehus, Holbaek Sygehus, Regionshospital Nordjylland, Hvidovre University Hospital, Amager Hospital
Leads: Herlev Hospital

This content was sourced from clinicaltrials.gov