Department of Emergency Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
J Am Heart Assoc. 2024 May 7;13(9):e033493. doi: 10.1161/JAHA.123.033493. Epub 2024 Apr 19.
Cardiac troponins are the preferred biomarkers for the diagnosis of acute myocardial infarction. Although sex-specific 99th percentile thresholds of troponins are recommended in international guidelines, the clinical effect of their use is poorly investigated. The DANSPOT Study (The Danish Study of Sex- and Population-Specific 99th percentile upper reference limits of Troponin) aims to evaluate the clinical effect of a prospective implementation of population- and sex-specific diagnostic thresholds of troponins into clinical practice.
This study is a nationwide, multicenter, stepped-wedge cluster-randomized trial of the implementation of population- and sex-specific thresholds of troponins in 22 of 23 clinical centers in Denmark. We established sex-specific thresholds for 5 different troponin assays based on troponin levels in a healthy Danish reference population. Centers will sequentially cross over from current uniform manufacturer-derived thresholds to the new population- and sex-specific thresholds. The primary cohort is defined as patients with symptoms suggestive of acute coronary syndrome having at least 1 troponin measurement performed within 24 hours of arrival with a peak troponin value between the current uniform threshold and the new sex-specific female and male thresholds. The study will compare the occurrence of the primary outcome, defined as a composite of nonfatal myocardial infarction, unplanned revascularization, and all-cause mortality within 1 year, separately for men and women before and after the implementation of the new sex-specific thresholds.
The DANSPOT Study is expected to show the clinical effects on diagnostics, treatment, and clinical outcomes in patients with myocardial infarction of implementing sex-specific diagnostic thresholds for troponin based on a national Danish reference population.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT05336435.
心肌肌钙蛋白是诊断急性心肌梗死的首选生物标志物。尽管国际指南推荐使用基于性别特异的 99 百分位阈值，但它们的临床应用效果尚未得到充分研究。DANSPOT 研究（丹麦基于性别和人群特异的肌钙蛋白 99 百分位上限参考值的研究）旨在评估将人群和性别特异的肌钙蛋白诊断阈值前瞻性地应用于临床实践中的临床效果。
本研究是一项在丹麦 23 个临床中心中的 22 个中心进行的全国性、多中心、阶梯式楔形集群随机试验，旨在实施基于健康丹麦参考人群的肌钙蛋白水平的 5 种不同肌钙蛋白检测方法的性别特异阈值。中心将依次从当前的统一制造商衍生的阈值交叉到新的人群和性别特异的阈值。主要队列定义为有急性冠状动脉综合征症状且在到达后 24 小时内至少有 1 次肌钙蛋白测量、峰值肌钙蛋白值在当前统一阈值和新的性别特异女性和男性阈值之间的患者。该研究将比较在实施新的性别特异阈值前后，男性和女性患者在 1 年内发生非致命性心肌梗死、计划外血运重建和全因死亡率的复合主要结局的发生率。
DANSPOT 研究有望显示出在基于全国丹麦参考人群的肌钙蛋白性别特异诊断阈值方面，对心肌梗死患者的诊断、治疗和临床结局的临床效果。
