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 Hansen

Pia Rørbæk Kamstrup, Henning Bundgaard, Christian Torp-Pedersen, Kasper Karmark Iversen

^*Corresponding author for this work

Research output: Contribution to journal › Article › Research › 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.

Original language	English
Article number	e033493
Number of pages	11
Journal	Journal of the American Heart Association
Volume	13
Issue number	9
Early online date	19 Apr 2024
DOIs	https://doi.org/10.1161/JAHA.123.033493
Publication status	Published - 7 May 2024

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

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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
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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), Article 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 = "American Heart Association Inc.",

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, vol. 13, no. 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.
In: Journal of the American Heart Association, Vol. 13, No. 9, e033493, 07.05.2024.

Research output: Contribution to journal › Article › Research › 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

Keywords

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Kønsspecifikke troponin-grænseværdier kan potentielt redde kvindeliv

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