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Cardiac troponin is central to the diagnosis of myocardial infarction and high-sensitivity cardiac troponin (hs-cTn) assays are the preferred choice for the assessment of patients with suspected acute coronary syndrome.
Since the introduction of hs-cTn assays in Europe in 2010, most hospitals have switched from contemporary sensitive cardiac troponin assays to a hs-cTn assay. The implementation of hs-cTn assays has led to an increase in the number of patients identified with myocardial injury. Although both hs-cTnI and hs-cTnT assays are recommended in current guidelines, the impact of switching from a hs-cTnI assay to a hs-cTnT assay on clinical practice is unknown. At this point, no studies have evaluated the impact of implementing sex-specific hs-cTnT thresholds on the diagnosis of myocardial infarction and outcome in clinical practice.
The investigators propose to determine the proportion of patients with and without myocardial injury admitted to the hospital before and after implementation of a hs-cTnT assay and to evaluate the impact on investigations, care and clinical outcomes in consecutive patients with suspected acute coronary syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-implementation group | Clinical use of hs-cTnI in patients with suspected acute coronary syndrome | ||
| Post-implementation group | Clinical use of hs-cTnT in patients with suspected acute coronary syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical implementation of hs-cTnT | Diagnostic Test | To investigate the clinical impact on the transition from a hs-cTnI assay to a hs-cTnT assay in consecutive patients presenting to the Emergency Department or Acute Medical Unit with suspected acute coronary syndrome. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with suspected acute coronary syndrome admitted to hospital | To determine the proportion of patients with and without myocardial injury admitted to the hospital before and after implementation of the hs-cTnT assay | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with myocardial injury admitted to hospital | To determine the proportion of patients with myocardial injury admitted to hospital | Up to 24 hours |
| Length of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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All patients presenting to an Emergency Department or an Acute Medical Unit in NHS Lothian between October 25th 2020 and October 25th 2022 where the attending clinician measures cardiac troponin for suspected acute coronary syndrome will be identified by NHS Lothian staff or the research team using an existing screening tool embedded into the ordering of cardiac troponin testing.
We will compare the clinical impact of two guideline recommended high-sensitivity cardiac troponin assays in routine health care. We will not seek individual patient consent as this is an evaluation of a change in routine clinical care using approved tests, there are no specific research procedures, and we wish to evaluate performance in those patients in whom clinicians apply the test to avoid selection bias.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Cardiovascular Science | Edinburgh | EH16 4SB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30571511 | Background | Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available. | |
| 30170853 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D002637 | Chest Pain |
| D006333 | Heart Failure |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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To determine the length of hospital stay
| Up to 30 days |
| Clinical diagnosis of myocardial infarction | To determine the prevalence of myocardial infarction | Up to 24 hours |
| Clinical diagnosis of heart failure | To determine the prevalence of heart failure | Up to 24 hours |
| Coronary angiography during hospital admission | To determine the number of coronary angiograms performed during hospital admission | Up to 30 days |
| Echocardiography during hospital admission | To determine the number of echocardiograms performed during hospital admission | Up to 30 days |
| New prescription of evidence-based treatment for coronary artery disease or heart failure following discharge | To determine the number of new prescriptions of evidence-based treatment for coronary artery disease or heart failure following discharge | Up to 30 days |
| Revascularization at 30 days and one year | To determine the rate of coronary revascularization at 30 days and one year | 30 days and 1 year |
| Reattendance with suspected acute coronary syndrome at 30 days and one year | To determine the rate of reattendance with suspected acute coronary syndrome at 30 days and one year | 30 days and 1 year |
| Subsequent myocardial infarction at 30 days and one year | To determine the prevalence of subsequent myocardial infarction at 30 days and one year | 30 days and 1 year |
| Subsequent heart failure at 30 days and one year | To determine the prevalence of subsequent heart failure at 30 days and one year | 30 days and 1 year |
| Subsequent myocardial infarction, heart failure or cardiovascular death at 30 days and one year | To determine the prevalence of subsequent myocardial infarction, heart failure or cardiovascular death at 30 days and one year | 30 days and 1 year |
| Cardiovascular death at 30 days and one year | To determine the prevalence of cardiovascular death at 30 days and one year | 30 days and 1 year |
| All-cause death at 30 days and one year | To determine the prevalence of all-cause death at 30 days and one year | 30 days and 1 year |
| Background |
| Shah ASV, Anand A, Strachan FE, Ferry AV, Lee KK, Chapman AR, Sandeman D, Stables CL, Adamson PD, Andrews JPM, Anwar MS, Hung J, Moss AJ, O'Brien R, Berry C, Findlay I, Walker S, Cruickshank A, Reid A, Gray A, Collinson PO, Apple FS, McAllister DA, Maguire D, Fox KAA, Newby DE, Tuck C, Harkess R, Parker RA, Keerie C, Weir CJ, Mills NL; High-STEACS Investigators. High-sensitivity troponin in the evaluation of patients with suspected acute coronary syndrome: a stepped-wedge, cluster-randomised controlled trial. Lancet. 2018 Sep 15;392(10151):919-928. doi: 10.1016/S0140-6736(18)31923-8. Epub 2018 Aug 28. |
| 31623760 | Background | Lee KK, Ferry AV, Anand A, Strachan FE, Chapman AR, Kimenai DM, Meex SJR, Berry C, Findlay I, Reid A, Cruickshank A, Gray A, Collinson PO, Apple FS, McAllister DA, Maguire D, Fox KAA, Newby DE, Tuck C, Keerie C, Weir CJ, Shah ASV, Mills NL; High-STEACS Investigators. Sex-Specific Thresholds of High-Sensitivity Troponin in Patients With Suspected Acute Coronary Syndrome. J Am Coll Cardiol. 2019 Oct 22;74(16):2032-2043. doi: 10.1016/j.jacc.2019.07.082. |
| 33585931 | Background | Mjoen G, Maggiore U, Kessaris N, Kimenai D, Watschinger B, Mariat C, Sever MS, Crespo M, Peruzzi L, Spasovski G, Sorensen SS, Heemann U, Pascual J, Viklicky O, Courtney AE, Hadaya K, Wagner L, Nistor I, Hadjianastassiou V, Durlik M, Helantera I, Oberbauer R, Oniscu G, Hilbrands L, Abramowicz D. Long-term risks after kidney donation: how do we inform potential donors? A survey from DESCARTES and EKITA transplantation working groups. Nephrol Dial Transplant. 2021 Aug 27;36(9):1742-1753. doi: 10.1093/ndt/gfab035. |
| 23164485 | Background | Reichlin T, Twerenbold R, Reiter M, Steuer S, Bassetti S, Balmelli C, Winkler K, Kurz S, Stelzig C, Freese M, Drexler B, Haaf P, Zellweger C, Osswald S, Mueller C. Introduction of high-sensitivity troponin assays: impact on myocardial infarction incidence and prognosis. Am J Med. 2012 Dec;125(12):1205-1213.e1. doi: 10.1016/j.amjmed.2012.07.015. |
| 26454362 | Background | Shah AS, Anand A, Sandoval Y, Lee KK, Smith SW, Adamson PD, Chapman AR, Langdon T, Sandeman D, Vaswani A, Strachan FE, Ferry A, Stirzaker AG, Reid A, Gray AJ, Collinson PO, McAllister DA, Apple FS, Newby DE, Mills NL; High-STEACS investigators. High-sensitivity cardiac troponin I at presentation in patients with suspected acute coronary syndrome: a cohort study. Lancet. 2015 Dec 19;386(10012):2481-8. doi: 10.1016/S0140-6736(15)00391-8. Epub 2015 Oct 8. |
| 29127948 | Background | Chapman AR, Lee KK, McAllister DA, Cullen L, Greenslade JH, Parsonage W, Worster A, Kavsak PA, Blankenberg S, Neumann J, Sorensen NA, Westermann D, Buijs MM, Verdel GJE, Pickering JW, Than MP, Twerenbold R, Badertscher P, Sabti Z, Mueller C, Anand A, Adamson P, Strachan FE, Ferry A, Sandeman D, Gray A, Body R, Keevil B, Carlton E, Greaves K, Korley FK, Metkus TS, Sandoval Y, Apple FS, Newby DE, Shah ASV, Mills NL. Association of High-Sensitivity Cardiac Troponin I Concentration With Cardiac Outcomes in Patients With Suspected Acute Coronary Syndrome. JAMA. 2017 Nov 21;318(19):1913-1924. doi: 10.1001/jama.2017.17488. |
| 28034899 | Background | Chapman AR, Anand A, Boeddinghaus J, Ferry AV, Sandeman D, Adamson PD, Andrews J, Tan S, Cheng SF, D'Souza M, Orme K, Strachan FE, Nestelberger T, Twerenbold R, Badertscher P, Reichlin T, Gray A, Shah ASV, Mueller C, Newby DE, Mills NL. Comparison of the Efficacy and Safety of Early Rule-Out Pathways for Acute Myocardial Infarction. Circulation. 2017 Apr 25;135(17):1586-1596. doi: 10.1161/CIRCULATIONAHA.116.025021. Epub 2016 Dec 29. |
| 29844245 | Background | Kimenai DM, Janssen EBNJ, Eggers KM, Lindahl B, den Ruijter HM, Bekers O, Appelman Y, Meex SJR. Sex-Specific Versus Overall Clinical Decision Limits for Cardiac Troponin I and T for the Diagnosis of Acute Myocardial Infarction: A Systematic Review. Clin Chem. 2018 Jul;64(7):1034-1043. doi: 10.1373/clinchem.2018.286781. Epub 2018 May 29. |
| 22983113 | Background | Apple FS, Ler R, Murakami MM. Determination of 19 cardiac troponin I and T assay 99th percentile values from a common presumably healthy population. Clin Chem. 2012 Nov;58(11):1574-81. doi: 10.1373/clinchem.2012.192716. Epub 2012 Sep 14. |
| 30626631 | Background | Anand A, Shah ASV, Beshiri A, Jaffe AS, Mills NL. Global Adoption of High-Sensitivity Cardiac Troponins and the Universal Definition of Myocardial Infarction. Clin Chem. 2019 Mar;65(3):484-489. doi: 10.1373/clinchem.2018.298059. Epub 2019 Jan 9. |
| 32860058 | Background | Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available. |
| 25948541 | Background | Wildi K, Gimenez MR, Twerenbold R, Reichlin T, Jaeger C, Heinzelmann A, Arnold C, Nelles B, Druey S, Haaf P, Hillinger P, Schaerli N, Kreutzinger P, Tanglay Y, Herrmann T, Moreno Weidmann Z, Krivoshei L, Freese M, Stelzig C, Puelacher C, Rentsch K, Osswald S, Mueller C. Misdiagnosis of Myocardial Infarction Related to Limitations of the Current Regulatory Approach to Define Clinical Decision Values for Cardiac Troponin. Circulation. 2015 Jun 9;131(23):2032-40. doi: 10.1161/CIRCULATIONAHA.114.014129. Epub 2015 May 6. |
| 27330150 | Background | Kimenai DM, Gerritse BM, Lucas C, Rosseel PM, Bentala M, van Hattum P, van der Meer NJ, Scohy TV. Effectiveness of pericardial lavage with or without tranexamic acid in cardiac surgery patients receiving intravenous tranexamic acid: a randomized controlled trial. Eur J Cardiothorac Surg. 2016 Dec;50(6):1124-1131. doi: 10.1093/ejcts/ezw214. Epub 2016 Jun 21. |
| 30227114 | Background | Mueller T, Egger M, Peer E, Jani E, Dieplinger B. Evaluation of sex-specific cut-off values of high-sensitivity cardiac troponin I and T assays in an emergency department setting - Results from the Linz Troponin (LITROP) study. Clin Chim Acta. 2018 Dec;487:66-74. doi: 10.1016/j.cca.2018.09.026. Epub 2018 Sep 15. |
| 22125306 | Background | Ungerer JP, Marquart L, O'Rourke PK, Wilgen U, Pretorius CJ. Concordance, variance, and outliers in 4 contemporary cardiac troponin assays: implications for harmonization. Clin Chem. 2012 Jan;58(1):274-83. doi: 10.1373/clinchem.2011.175059. Epub 2011 Nov 28. |
| Background | McDonald S, Furmuga J, Vigen R, et al. Assessment of agreement of two high sensitivity troponin assays during an institutional transition. Vessel Plus. 2021;5(38):1-8. |
| 33766254 | Background | Karady J, Mayrhofer T, Ferencik M, Nagurney JT, Udelson JE, Kammerlander AA, Fleg JL, Peacock WF, Januzzi JL Jr, Koenig W, Hoffmann U. Discordance of High-Sensitivity Troponin Assays in Patients With Suspected Acute Coronary Syndromes. J Am Coll Cardiol. 2021 Mar 30;77(12):1487-1499. doi: 10.1016/j.jacc.2021.01.046. |
| 33752439 | Background | Anand A, Lee KK, Chapman AR, Ferry AV, Adamson PD, Strachan FE, Berry C, Findlay I, Cruikshank A, Reid A, Collinson PO, Apple FS, McAllister DA, Maguire D, Fox KAA, Newby DE, Tuck C, Harkess R, Keerie C, Weir CJ, Parker RA, Gray A, Shah ASV, Mills NL; HiSTORIC Investigatorsdagger. High-Sensitivity Cardiac Troponin on Presentation to Rule Out Myocardial Infarction: A Stepped-Wedge Cluster Randomized Controlled Trial. Circulation. 2021 Jun 8;143(23):2214-2224. doi: 10.1161/CIRCULATIONAHA.120.052380. Epub 2021 Mar 23. |
| 41405901 | Derived | Boeddinghaus J, Li Z, Bularga A, Taggart C, Wereski R, Chapman AR, Lee KK, Tuck C, Gunn R, Jenks S, McCance K, Pattenden R, Malo J, Thurston AJF, Tew YY, McDermott M, Gray A, Cruden NLM, Anand A, Kimenai DM, Mills NL; TWITCH-ED Investigators. Clinical Decisions and Outcomes After Switching High-Sensitivity Cardiac Troponin Assays in Suspected ACS: An Interrupted Time-Series Study. JAMA Cardiol. 2026 Feb 1;11(2):186-192. doi: 10.1001/jamacardio.2025.4661. |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012725 | Sexual Behavior |
| D001519 | Behavior |