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

Nina Strandkjær; Nicoline Jørgensen; Rasmus Bo Hasselbalch; Jonas Kristensen; Marie Sophie Sander Knudsen; Thilde Olivia Kock; Theis Lange; Matias Greve Lindholm; Niels Eske Bruun; Lene Holmvang; Christian Juhl Terkelsen; Claus Kjær Pedersen; Martin Kirk Christensen; Jens Flensted Lassen; Linda Hilsted; Søren Ladefoged; Mads Nybo; Mustafa Vakur Bor; Morten Dahl; Annebirthe Bo Hansen; Pia Rørbæk Kamstrup; Henning Bundgaard; Christian Torp-Pedersen; Kasper Karmark Iversen

doi:10.1161/JAHA.123.033493

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

Nina Strandkjær^*, Nicoline Jørgensen, Rasmus Bo Hasselbalch, Jonas Kristensen, Marie Sophie Sander Knudsen, Thilde Olivia Kock, Theis Lange, Matias Greve Lindholm, Niels Eske Bruun, Lene Holmvang, Christian Juhl Terkelsen, Claus Kjær Pedersen, Martin Kirk Christensen, Jens Flensted Lassen, Linda Hilsted, Søren Ladefoged, Mads Nybo, Mustafa Vakur Bor, Morten Dahl, Annebirthe Bo HansenPia Rørbæk Kamstrup, Henning Bundgaard, Christian Torp-Pedersen, Kasper Karmark Iversen

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift › Artikel › Forskning › peer review

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.

Originalsprog	Engelsk
Artikelnummer	e033493
Antal sider	11
Tidsskrift	Journal of the American Heart Association
Vol/bind	13
Udgave nummer	9
Tidlig onlinedato	19 apr. 2024
DOI	https://doi.org/10.1161/JAHA.123.033493
Status	Udgivet - 7 maj 2024

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10.1161/JAHA.123.033493

Kønsspecifikke troponin-grænseværdier kan potentielt redde kvindeliv
Lindholm, M. G., Bruun, N. E. & Dahl, M.
15/05/24
1 element af Mediedækning
Presse/medie

Citationsformater

Strandkjær, N., Jørgensen, N., Hasselbalch, R. B., Kristensen, J., Knudsen, M. S. S., Kock, T. O., Lange, T., Lindholm, M. G., Bruun, N. E., Holmvang, L., Terkelsen, C. J., Pedersen, C. K., Christensen, M. K., Lassen, J. F., Hilsted, L., Ladefoged, S., Nybo, M., Bor, M. V., Dahl, M., ... Iversen, K. K. (2024). Danspot: A Multicenter Stepped-Wedge Cluster-Randomized Trial of the Reclassification of Acute Myocardial Infarction: Rationale and Study Design. Journal of the American Heart Association, 13(9), Artikel e033493. https://doi.org/10.1161/JAHA.123.033493

@article{14cdcbccf35948d7bad324e46e48a619,

title = "Danspot: A Multicenter Stepped-Wedge Cluster-Randomized Trial of the Reclassification of Acute Myocardial Infarction: Rationale and Study Design",

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.",

keywords = "Biomarkers/blood, Denmark/epidemiology, Female, Humans, Male, Myocardial Infarction/blood, Predictive Value of Tests, Prospective Studies, Randomized Controlled Trials as Topic, Sex Factors, Troponin/blood",

author = "Nina Strandkj{\ae}r and Nicoline J{\o}rgensen and Hasselbalch, {Rasmus Bo} and Jonas Kristensen and Knudsen, {Marie Sophie Sander} and Kock, {Thilde Olivia} and Theis Lange and Lindholm, {Matias Greve} and Bruun, {Niels Eske} and Lene Holmvang and Terkelsen, {Christian Juhl} and Pedersen, {Claus Kj{\ae}r} and Christensen, {Martin Kirk} and Lassen, {Jens Flensted} and Linda Hilsted and S{\o}ren Ladefoged and Mads Nybo and Bor, {Mustafa Vakur} and Morten Dahl and Hansen, {Annebirthe Bo} and Kamstrup, {Pia R{\o}rb{\ae}k} and Henning Bundgaard and Christian Torp-Pedersen and Iversen, {Kasper Karmark}",

year = "2024",

month = may,

day = "7",

doi = "10.1161/JAHA.123.033493",

language = "English",

volume = "13",

journal = "Journal of the American Heart Association",

issn = "2047-9980",

publisher = "Wiley-Blackwell",

number = "9",

}

Strandkjær, N, Jørgensen, N, Hasselbalch, RB, Kristensen, J, Knudsen, MSS, Kock, TO, Lange, T, Lindholm, MG , Bruun, NE, Holmvang, L, Terkelsen, CJ, Pedersen, CK, Christensen, MK, Lassen, JF, Hilsted, L, Ladefoged, S, Nybo, M, Bor, MV, Dahl, M, Hansen, AB, Kamstrup, PR, Bundgaard, H, Torp-Pedersen, C & Iversen, KK 2024, 'Danspot: A Multicenter Stepped-Wedge Cluster-Randomized Trial of the Reclassification of Acute Myocardial Infarction: Rationale and Study Design', Journal of the American Heart Association, bind 13, nr. 9, e033493. https://doi.org/10.1161/JAHA.123.033493

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 et al.
I: Journal of the American Heart Association, Bind 13, Nr. 9, e033493, 07.05.2024.

Publikation: Bidrag til tidsskrift › Artikel › Forskning › peer review

TY - JOUR

T1 - Danspot

T2 - A Multicenter Stepped-Wedge Cluster-Randomized Trial of the Reclassification of Acute Myocardial Infarction: Rationale and Study Design

AU - Strandkjær, Nina

AU - Jørgensen, Nicoline

AU - Hasselbalch, Rasmus Bo

AU - Kristensen, Jonas

AU - Knudsen, Marie Sophie Sander

AU - Kock, Thilde Olivia

AU - Lange, Theis

AU - Lindholm, Matias Greve

AU - Bruun, Niels Eske

AU - Holmvang, Lene

AU - Terkelsen, Christian Juhl

AU - Pedersen, Claus Kjær

AU - Christensen, Martin Kirk

AU - Lassen, Jens Flensted

AU - Hilsted, Linda

AU - Ladefoged, Søren

AU - Nybo, Mads

AU - Bor, Mustafa Vakur

AU - Dahl, Morten

AU - Hansen, Annebirthe Bo

AU - Kamstrup, Pia Rørbæk

AU - Bundgaard, Henning

AU - Torp-Pedersen, Christian

AU - Iversen, Kasper Karmark

PY - 2024/5/7

Y1 - 2024/5/7

N2 - 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.

AB - 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.

KW - Biomarkers/blood

KW - Denmark/epidemiology

KW - Female

KW - Humans

KW - Male

KW - Myocardial Infarction/blood

KW - Predictive Value of Tests

KW - Prospective Studies

KW - Randomized Controlled Trials as Topic

KW - Sex Factors

KW - Troponin/blood

U2 - 10.1161/JAHA.123.033493

DO - 10.1161/JAHA.123.033493

M3 - Article

C2 - 38639348

SN - 2047-9980

VL - 13

JO - Journal of the American Heart Association

JF - Journal of the American Heart Association

IS - 9

M1 - e033493

ER -

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

Abstract

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Fingeraftryk

Presse/Medier

Kønsspecifikke troponin-grænseværdier kan potentielt redde kvindeliv

Citationsformater