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DANSPOT: A Multicenter Stepped-Wedge Cluster-Randomized Trial of the Reclassification of Acute Myocardial Infarction: Rationale and Study Design.
Strandkjær, Nina; Jørgensen, Nicoline; Hasselbalch, Rasmus Bo; Kristensen, Jonas; Knudsen, Marie Sophie Sander; Kock, Thilde Olivia; Lange, Theis; Lindholm, Matias Greve; Bruun, Niels Eske; Holmvang, Lene; Terkelsen, Christian Juhl; Pedersen, Claus Kjær; Christensen, Martin Kirk; Lassen, Jens Flensted; Hilsted, Linda; Ladefoged, Søren; Nybo, Mads; Bor, Mustafa Vakur; Dahl, Morten; Hansen, Annebirthe Bo; Kamstrup, Pia Rørbæk; Bundgaard, Henning; Torp-Pedersen, Christian; Iversen, Kasper Karmark.
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  • Strandkjær N; Department of Emergency Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
  • Jørgensen N; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
  • Hasselbalch RB; Department of Clinical Medicine University of Copenhagen Denmark.
  • Kristensen J; Department of Emergency Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
  • Knudsen MSS; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
  • Kock TO; Department of Emergency Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
  • Lange T; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
  • Lindholm MG; Department of Clinical Medicine University of Copenhagen Denmark.
  • Bruun NE; Department of Emergency Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
  • Holmvang L; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
  • Terkelsen CJ; Department of Clinical Medicine University of Copenhagen Denmark.
  • Pedersen CK; Department of Emergency Medicine Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
  • Christensen MK; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
  • Lassen JF; Department of Cardiology Copenhagen University Hospital-Herlev and Gentofte Herlev Denmark.
  • Hilsted L; Department of Public Health University of Copenhagen Denmark.
  • Ladefoged S; Department of Cardiology Zealand University Hospital Roskilde Denmark.
  • Nybo M; Department of Clinical Medicine University of Copenhagen Denmark.
  • Bor MV; Department of Cardiology Zealand University Hospital Roskilde Denmark.
  • Dahl M; Department of Cardiology Copenhagen University Hospital-Rigshospitalet Copenhagen Denmark.
  • Hansen AB; Department of Cardiology Aarhus University Hospital Aarhus Denmark.
  • Kamstrup PR; Department of Cardiology Aarhus University Hospital Aarhus Denmark.
  • Bundgaard H; Department of Cardiology Aalborg University Hospital Aalborg Denmark.
  • Torp-Pedersen C; Department of Cardiology Odense University Hospital Odense Denmark.
  • Iversen KK; Department of Clinical Biochemistry Copenhagen University Hospital-Rigshospitalet Copenhagen Denmark.
J Am Heart Assoc ; 13(9): e033493, 2024 May 07.
Article en En | MEDLINE | ID: mdl-38639348
ABSTRACT

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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Troponina / Biomarcadores / Infarto del Miocardio Límite: Female / Humans / Male País/Región como asunto: Europa Idioma: En Revista: J Am Heart Assoc Año: 2024 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Troponina / Biomarcadores / Infarto del Miocardio Límite: Female / Humans / Male País/Región como asunto: Europa Idioma: En Revista: J Am Heart Assoc Año: 2024 Tipo del documento: Article Pais de publicación: Reino Unido