NCT05336435: DANSPOT

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

Status unknown NA Last updated 17 October 2023

What this trial tests

NA trial testing Implementation of the new population and sex-specific 99th percentile URL for cardiac troponin in Coronary Syndrome, Acute in 7,500 participants. Status unknown.

Timeline

1 April 2022

Primary endpoint
28 February 2025

28 February 2025

Quick facts

Lead sponsor	Herlev Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	diagnostic
Enrollment	7,500
Start date	1 April 2022
Primary completion	28 February 2025
Estimated completion	28 February 2025
Sites	22 locations across Denmark

Drugs / interventions tested

• Implementation of the new population and sex-specific 99th percentile URL for cardiac troponin

Conditions studied

• Coronary Syndrome, Acute — all drugs for Coronary Syndrome, Acute →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Myocardial Infarction — all drugs for Myocardial Infarction →

Sponsor

Herlev Hospital

Who can join

18 and older, any sex, with Coronary Syndrome, Acute or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. DANSPOT: A Multicenter Stepped-Wedge Cluster-Randomized Trial of the Reclassification of Acute Myocardial Infarction: Rationale and Study Design.
   Strandkjær N, Jørgensen N, Hasselbalch RB, Kristensen J, et al · · 2024 · cited 4× · PMID 38639348 · DOI 10.1161/jaha.123.033493
2. Serial troponin-I and long-term outcomes in subjects with suspected acute coronary syndrome.
   Pareek M, Kristensen AMD, Vaduganathan M, Byrne C, et al · · 2024 · cited 3× · PMID 38057157 · DOI 10.1093/eurjpc/zwad373
3. Impact of age on cardiac troponin concentration among healthy individuals.
   Hasselbalch RB, Strandkjær N, Kristensen J, Jørgensen N, et al · · 2025 · cited 2× · PMID 40513714 · DOI 10.1016/j.clinbiochem.2025.110956