DANSPOT: A Multicenter Stepped-Wedge Cluster-Randomized Trial of the Reclassification of Acute Myocardial Infarction: Rationale and Study Design.

Autor: Strandkjær N; Department of Emergency Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.; Department of Clinical Medicine University of Copenhagen Denmark., Jørgensen N; Department of Emergency Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark., Hasselbalch RB; Department of Emergency Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.; Department of Clinical Medicine University of Copenhagen Denmark., Kristensen J; Department of Emergency Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.; Department of Clinical Medicine University of Copenhagen Denmark., Knudsen MSS; Department of Emergency Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark., Kock TO; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark., Lange T; Department of Public Health University of Copenhagen Denmark., Lindholm MG; Department of Cardiology Zealand University Hospital Roskilde Denmark., Bruun NE; Department of Clinical Medicine University of Copenhagen Denmark.; Department of Cardiology Zealand University Hospital Roskilde Denmark., Holmvang L; Department of Cardiology Copenhagen University Hospital-Rigshospitalet Copenhagen Denmark., Terkelsen CJ; Department of Cardiology Aarhus University Hospital Aarhus Denmark., Pedersen CK; Department of Cardiology Aarhus University Hospital Aarhus Denmark., Christensen MK; Department of Cardiology Aalborg University Hospital Aalborg Denmark., Lassen JF; Department of Cardiology Odense University Hospital Odense Denmark., Hilsted L; Department of Clinical Biochemistry Copenhagen University Hospital-Rigshospitalet Copenhagen Denmark., Ladefoged S; Department of Clinical Biochemistry Aarhus University Hospital Aarhus Denmark., Nybo M; Department of Clinical Biochemistry Odense University Hospital Odense Denmark., Bor MV; Department of Clinical Biochemistry University of Hospital of South Denmark Esbjerg Denmark., Dahl M; Department of Clinical Medicine University of Copenhagen Denmark.; Department of Clinical Biochemistry Zealand University Hospital Køge Denmark., Hansen AB; Department of Clinical Biochemistry Aalborg University Hospital Aalborg Denmark., Kamstrup PR; Department of Clinical Biochemistry Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark., Bundgaard H; Department of Clinical Medicine University of Copenhagen Denmark.; Department of Cardiology Copenhagen University Hospital-Rigshospitalet Copenhagen Denmark., Torp-Pedersen C; Department of Public Health University of Copenhagen Denmark.; Department of Cardiology Copenhagen University Hospital-North Zealand Hillerød Denmark., Iversen KK; Department of Emergency Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.; Department of Clinical Medicine University of Copenhagen Denmark.; Department of Internal Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
Jazyk: angličtina
Zdroj: Journal of the American Heart Association [J Am Heart Assoc] 2024 May 07; Vol. 13 (9), pp. e033493. Date of Electronic Publication: 2024 Apr 19.
DOI: 10.1161/JAHA.123.033493
Abstrakt: Background: 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.
Methods: 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.
Conclusions: 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.
Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05336435.
Databáze: MEDLINE
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