NCT01852123

Brief Summary

In patients with chest pain the diagnosis of a heart attack (myocardial infarction) is made where there is evidence of heart muscle damage using a blood test to measure the heart muscle protein troponin. A new a more sensitive troponin test may help us to identify patients with myocardial infarction more easily. The investigators propose to evaluate whether use of a novel high-sensitivity troponin test to lower the threshold for diagnosis of myocardial infarction is appropriate. If increased sensitivity does not reduce specificity for the diagnosis, then this new test will improve patient outcome through better targeting of therapies for coronary heart disease. However, if increased sensitivity leads to poor specificity, then patients may be misdiagnosed and given inappropriate cardiac medications with potentially detrimental outcomes. In ten secondary and tertiary care hospitals across Scotland, the investigators will undertake a stepped wedge cluster randomized controlled trial of the implementation of a novel high-sensitivity troponin test. The primary end-point will be the one-year rate of cardiovascular death or recurrent myocardial infarction. This will establish whether the introduction of this high-sensitivity troponin test into routine clinical practice is beneficial to patient management and outcomes. A subset of patients will be asked to give consent for inclusion into a sub-study that will permit storage of blood samples and will require the completion of a survey during the index admission and after 6 and 12 months of follow up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48,282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
28 days until next milestone

Study Start

First participant enrolled

June 10, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2017

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

3.7 years

First QC Date

April 29, 2013

Last Update Submit

June 18, 2021

Conditions

Acute Coronary SyndromeMyocardial Infarction

Keywords

High-sensitivity troponin assayMyocardial infarctionUnstable anginaMyocardial injuryCluster randomized trial

Outcome Measures

Primary Outcomes (1)

  • Recurrent myocardial infarction or cardiovascular death at 1 year

    1 year

Secondary Outcomes (10)

  • Duration of stay

    Initial episode

  • Recurrent myocardial infarction

    1 year

  • Unplanned coronary revascularization

    1 year

  • Cardiovascular death

    1 year

  • All cause death

    1 year

  • +5 more secondary outcomes

Other Outcomes (3)

  • Physician diagnosis on discharge

    Duration of the index hospital stay, an expected average of 2 weeks

  • Sensitivity and specificity of sex-specific thresholds for the diagnosis of myocardial infarction

    3 months

  • Evaluate thresholds to rule out myocardial infarction on presentation and change criteria to rule in myocardial infarction with serial sampling.

    6 months

Study Arms (2)

Early implementation

OTHER

The high-sensitivity troponin I assay will be implemented after a 6 month validation phase

Device: High-sensitivity troponin I assay

Late implementation

OTHER

The high-sensitivity troponin I assay will be implemented after a 12 month validation phase

Device: High-sensitivity troponin I assay

Interventions

High-sensitivity troponin I assayDEVICE
Also known as: ARCHITECT STAT high-sensitive troponin I assay
Early implementationLate implementation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Suspected acute coronary syndrome
  • Troponin I measurement as part of routine clinical care

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SB, United Kingdom

Location

Related Publications (19)

  • 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.

    PMID: 26454362RESULT

  • Lee KK, Doudesis D, Ferry AV, Chapman AR, Kimenai DM, Fujisawa T, Bularga A, Lowry MTH, Taggart C, Schulberg S, Wereski R, Tuck C, Strachan FE, Newby DE, Anand A, Shah ASV, Mills NL; High-STEACS Investigators. Implementation of a high sensitivity cardiac troponin I assay and risk of myocardial infarction or death at five years: observational analysis of a stepped wedge, cluster randomised controlled trial. BMJ. 2023 Nov 27;383:e075009. doi: 10.1136/bmj-2023-075009.

    PMID: 38011922DERIVED

  • Lowry MTH, Doudesis D, Boeddinghaus J, Kimenai DM, Bularga A, Taggart C, Wereski R, Ferry AV, Stewart SD, Tuck C, Koechlin L, Nestelberger T, Lopez-Ayala P, Hure G, Lee KK, Chapman AR, Newby DE, Anand A, Collinson PO, Mueller C, Mills NL; High-STEACS Investigators. Troponin in early presenters to rule out myocardial infarction. Eur Heart J. 2023 Aug 7;44(30):2846-2858. doi: 10.1093/eurheartj/ehad376.

    PMID: 37350492DERIVED

  • Neumann JT, Twerenbold R, Ojeda F, Aldous SJ, Allen BR, Apple FS, Babel H, Christenson RH, Cullen L, Di Carluccio E, Doudesis D, Ekelund U, Giannitsis E, Greenslade J, Inoue K, Jernberg T, Kavsak P, Keller T, Lee KK, Lindahl B, Lorenz T, Mahler SA, Mills NL, Mokhtari A, Parsonage W, Pickering JW, Pemberton CJ, Reich C, Richards AM, Sandoval Y, Than MP, Toprak B, Troughton RW, Worster A, Zeller T, Ziegler A, Blankenberg S; ARTEMIS study group. Personalized diagnosis in suspected myocardial infarction. Clin Res Cardiol. 2023 Sep;112(9):1288-1301. doi: 10.1007/s00392-023-02206-3. Epub 2023 May 2.

    PMID: 37131096DERIVED

  • Taggart C, Monterrubio-Gomez K, Roos A, Boeddinghaus J, Kimenai DM, Kadesjo E, Bularga A, Wereski R, Ferry A, Lowry M, Anand A, Lee KK, Doudesis D, Manolopoulou I, Nestelberger T, Koechlin L, Lopez-Ayala P, Mueller C, Mills NL, Vallejos CA, Chapman AR. Improving Risk Stratification for Patients With Type 2 Myocardial Infarction. J Am Coll Cardiol. 2023 Jan 17;81(2):156-168. doi: 10.1016/j.jacc.2022.10.025.

    PMID: 36631210DERIVED

  • Bularga A, Taggart C, Mendusic F, Kimenai DM, Wereski R, Lowry MTH, Lee KK, Ferry AV, Stewart SS, McAllister DA, Shah ASV, Anand A, Newby DE, Mills NL, Chapman AR; High-Sensitivity Troponin in the Evaluation of Patients with Suspected Acute Coronary Syndrome (High-STEACS) Investigators. Assessment of Oxygen Supply-Demand Imbalance and Outcomes Among Patients With Type 2 Myocardial Infarction: A Secondary Analysis of the High-STEACS Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2220162. doi: 10.1001/jamanetworkopen.2022.20162.

    PMID: 35816305DERIVED

  • Doudesis D, Lee KK, Yang J, Wereski R, Shah ASV, Tsanas A, Anand A, Pickering JW, Than MP, Mills NL; High-STEACS Investigators. Validation of the myocardial-ischaemic-injury-index machine learning algorithm to guide the diagnosis of myocardial infarction in a heterogenous population: a prespecified exploratory analysis. Lancet Digit Health. 2022 May;4(5):e300-e308. doi: 10.1016/S2589-7500(22)00025-5.

    PMID: 35461689DERIVED

  • Wereski R, Kimenai DM, Taggart C, Doudesis D, Lee KK, Lowry MTH, Bularga A, Lowe DJ, Fujisawa T, Apple FS, Collinson PO, Anand A, Chapman AR, Mills NL. Cardiac Troponin Thresholds and Kinetics to Differentiate Myocardial Injury and Myocardial Infarction. Circulation. 2021 Aug 17;144(7):528-538. doi: 10.1161/CIRCULATIONAHA.121.054302. Epub 2021 Jun 25.

    PMID: 34167318DERIVED

  • Hung J, Roos A, Kadesjo E, McAllister DA, Kimenai DM, Shah ASV, Anand A, Strachan FE, Fox KAA, Mills NL, Chapman AR, Holzmann MJ. Performance of the GRACE 2.0 score in patients with type 1 and type 2 myocardial infarction. Eur Heart J. 2021 Jul 8;42(26):2552-2561. doi: 10.1093/eurheartj/ehaa375.

    PMID: 32516805DERIVED

  • 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.

    PMID: 31623760DERIVED

  • Chapman AR, Adamson PD, Shah ASV, Anand A, Strachan FE, Ferry AV, Lee KK, Berry C, Findlay I, Cruikshank A, Reid A, Gray A, Collinson PO, Apple F, McAllister DA, Maguire D, Fox KAA, Vallejos CA, Keerie C, Weir CJ, Newby DE, Mills NL; High-STEACS Investigators. High-Sensitivity Cardiac Troponin and the Universal Definition of Myocardial Infarction. Circulation. 2020 Jan 21;141(3):161-171. doi: 10.1161/CIRCULATIONAHA.119.042960. Epub 2019 Oct 7.

    PMID: 31587565DERIVED

  • Bularga A, Lee KK, Stewart S, Ferry AV, Chapman AR, Marshall L, Strachan FE, Cruickshank A, Maguire D, Berry C, Findlay I, Shah ASV, Newby DE, Mills NL, Anand A. High-Sensitivity Troponin and the Application of Risk Stratification Thresholds in Patients With Suspected Acute Coronary Syndrome. Circulation. 2019 Nov 5;140(19):1557-1568. doi: 10.1161/CIRCULATIONAHA.119.042866. Epub 2019 Sep 1.

    PMID: 31475856DERIVED

  • Ferry AV, Anand A, Strachan FE, Mooney L, Stewart SD, Marshall L, Chapman AR, Lee KK, Jones S, Orme K, Shah ASV, Mills NL. Presenting Symptoms in Men and Women Diagnosed With Myocardial Infarction Using Sex-Specific Criteria. J Am Heart Assoc. 2019 Sep 3;8(17):e012307. doi: 10.1161/JAHA.119.012307. Epub 2019 Aug 20.

    PMID: 31431112DERIVED

  • Neumann JT, Twerenbold R, Ojeda F, Sorensen NA, Chapman AR, Shah ASV, Anand A, Boeddinghaus J, Nestelberger T, Badertscher P, Mokhtari A, Pickering JW, Troughton RW, Greenslade J, Parsonage W, Mueller-Hennessen M, Gori T, Jernberg T, Morris N, Liebetrau C, Hamm C, Katus HA, Munzel T, Landmesser U, Salomaa V, Iacoviello L, Ferrario MM, Giampaoli S, Kee F, Thorand B, Peters A, Borchini R, Jorgensen T, Soderberg S, Sans S, Tunstall-Pedoe H, Kuulasmaa K, Renne T, Lackner KJ, Worster A, Body R, Ekelund U, Kavsak PA, Keller T, Lindahl B, Wild P, Giannitsis E, Than M, Cullen LA, Mills NL, Mueller C, Zeller T, Westermann D, Blankenberg S; COMPASS-MI Study Group. Application of High-Sensitivity Troponin in Suspected Myocardial Infarction. N Engl J Med. 2019 Jun 27;380(26):2529-2540. doi: 10.1056/NEJMoa1803377.

    PMID: 31242362DERIVED

  • Chapman AR, Fujisawa T, Lee KK, Andrews JP, Anand A, Sandeman D, Ferry AV, Stewart S, Marshall L, Strachan FE, Gray A, Newby DE, Shah ASV, Mills NL. Novel high-sensitivity cardiac troponin I assay in patients with suspected acute coronary syndrome. Heart. 2019 Apr;105(8):616-622. doi: 10.1136/heartjnl-2018-314093. Epub 2018 Nov 15.

    PMID: 30442743DERIVED

  • Chapman AR, Hesse K, Andrews J, Lee KK, Anand A, Shah ASV, Sandeman D, Ferry AV, Jameson J, Piya S, Stewart S, Marshall L, Strachan FE, Gray A, Newby DE, Mills NL. High-Sensitivity Cardiac Troponin I and Clinical Risk Scores in Patients With Suspected Acute Coronary Syndrome. Circulation. 2018 Oct 16;138(16):1654-1665. doi: 10.1161/CIRCULATIONAHA.118.036426.

    PMID: 30354460DERIVED

  • 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.

    PMID: 30170853DERIVED

  • Miller-Hodges E, Anand A, Shah ASV, Chapman AR, Gallacher P, Lee KK, Farrah T, Halbesma N, Blackmur JP, Newby DE, Mills NL, Dhaun N. High-Sensitivity Cardiac Troponin and the Risk Stratification of Patients With Renal Impairment Presenting With Suspected Acute Coronary Syndrome. Circulation. 2018 Jan 30;137(5):425-435. doi: 10.1161/CIRCULATIONAHA.117.030320. Epub 2017 Oct 4.

    PMID: 28978551DERIVED

  • 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.

    PMID: 28034899DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial InfarctionAngina, Unstable

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Nicholas L Mills, MD, PhD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

  • Ian Ford, PhD

    University of Glasgow

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 13, 2013

Study Start

June 10, 2013

Primary Completion

March 3, 2017

Study Completion

March 3, 2017

Last Updated

June 24, 2021

Record last verified: 2021-06

Locations

GB(1)