Acute Coronary SyndromeHigh-STEACSNCT01852123
High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome
A study testing High-sensitivity troponin I assay in people with Acute Coronary Syndrome and Myocardial Infarction, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction
- What is being tested?
- High-sensitivity troponin I assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48,282 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jun 2013to 3 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suspected acute coronary syndrome
- Troponin I measurement as part of routine clinical care
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SB
About this study
Official title: High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome: A Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Being tested
- High-sensitivity troponin I assay
- Keywords
- High-sensitivity troponin assay, Myocardial infarction, Unstable angina, Myocardial injury, Cluster randomized trial
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-sensitivity troponin I assayDevice
Also called ARCHITECT STAT high-sensitive troponin I assay
| Study group | Role | What they receive |
|---|---|---|
| Early implementation | Other | The high-sensitivity troponin I assay will be implemented after a 6 month validation phase Receives: Device: High-sensitivity troponin I assay |
| Late implementation | Other | The high-sensitivity troponin I assay will be implemented after a 12 month validation phase Receives: Device: High-sensitivity troponin I assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent myocardial infarction or cardiovascular death at 1 year
Measured: 1 year
Secondary outcomes (10)
Duration of stay
Duration of the index hospital stay, an expected average of 2 weeks
Measured: Initial episode
Recurrent myocardial infarction
Measured: 1 year
Unplanned coronary revascularization
Measured: 1 year
Cardiovascular death
Measured: 1 year
All cause death
Measured: 1 year
Heart failure hospitalization
Measured: 1 year
Major hemorrhage
Measured: 1 year
Minor hemorrhage
Measured: 1 year
Recurrent unplanned hospitalization excluding acute coronary syndrome
Measured: 30 days
Non-cardiovascular death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study start10 Jun 2013
- Primary completion3 Mar 2017
- Study completion3 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48,282 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, NHS Greater Glasgow and Clyde, Abbott Diagnostics Division
- Responsible party
- Sponsor
- Investigators
- Nicholas L Mills, MD, PhD, Principal investigator, University of EdinburghIan Ford, PhD, Study chair, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852123
- Sponsor's protocol ID
- High-STEACS
- Other IDs
- SP/12/10/29922
- Acronym
- High-STEACS
- Status last verified
- Jun 2021
- First submitted
- 29 Apr 2013
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26454362Restan IZ, Tew YY, Steiro OT, Li Z, Tjora HL, Langorgen J, Omland T, Collinson P, Bjorneklett R, Vikenes K, Steinsvik T, Skadberg O, Mjelva OR, Larsen AI, Bonarjee VVS, Mills NL, Aakre KM. Exploring Sex-Specific High-Sensitivity Cardiac Troponin Thresholds for Rule-Out of Non-ST-Elevation Myocardial Infarction. Clin Chem. 2026 Aug 3;72(8):868-879. doi: 10.1093/clinchem/hvag030.
PubMed 42135070Lee 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.
PubMed 38011922Lowry 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.
PubMed 37350492Neumann 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.
PubMed 37131096Taggart 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.
PubMed 36631210Bularga 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.
PubMed 35816305Doudesis 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.
PubMed 35461689Wereski 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.
PubMed 34167318Hung 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.
PubMed 32516805Lee 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.
PubMed 31623760Chapman 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.
PubMed 31587565Bularga 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.
PubMed 31475856Ferry 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.
PubMed 31431112Neumann 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.
PubMed 31242362
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01852123
- Acronym / sponsor ID
- High-STEACS / High-STEACS
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Keywords
- High-sensitivity troponin assay, Myocardial infarction, Unstable angina, Myocardial injury, Cluster randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48,282 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, NHS Greater Glasgow and Clyde, Abbott Diagnostics Division
- Study start
- 10 Jun 2013 (actual)
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early implementation | Other | Device: High-sensitivity troponin I assayThe high-sensitivity troponin I assay will be implemented after a 6 month validation phase |
| Late implementation | Other | Device: High-sensitivity troponin I assayThe high-sensitivity troponin I assay will be implemented after a 12 month validation phase |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Suspected acute coronary syndrome
- Troponin I measurement as part of routine clinical care
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-sensitivity troponin I assayAlso: ARCHITECT STAT high-sensitive troponin I assay | Device | Early implementation, Late implementation |
Primary outcome
Recurrent myocardial infarction or cardiovascular death at 1 year
Time frame: 1 year
10 secondary outcomes
Duration of stay
Time frame: Initial episode
Recurrent myocardial infarction
Time frame: 1 year
Unplanned coronary revascularization
Time frame: 1 year
Cardiovascular death
Time frame: 1 year
All cause death
Time frame: 1 year
Heart failure hospitalization
Time frame: 1 year
Major hemorrhage
Time frame: 1 year
Minor hemorrhage
Time frame: 1 year
Recurrent unplanned hospitalization excluding acute coronary syndrome
Time frame: 30 days
Non-cardiovascular death
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Results publication: PubMed 26454362Shah 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.
- Derived from this study: PubMed 42135070Restan IZ, Tew YY, Steiro OT, Li Z, Tjora HL, Langorgen J, Omland T, Collinson P, Bjorneklett R, Vikenes K, Steinsvik T, Skadberg O, Mjelva OR, Larsen AI, Bonarjee VVS, Mills NL, Aakre KM. Exploring Sex-Specific High-Sensitivity Cardiac Troponin Thresholds for Rule-Out of Non-ST-Elevation Myocardial Infarction. Clin Chem. 2026 Aug 3;72(8):868-879. doi: 10.1093/clinchem/hvag030.
- Derived from this study: PubMed 38011922Lee 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.
- Derived from this study: PubMed 37350492Lowry 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.
- Derived from this study: PubMed 37131096Neumann 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.
- Derived from this study: PubMed 36631210Taggart 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.
- Derived from this study: PubMed 35816305Bularga 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.
- Derived from this study: PubMed 35461689Doudesis 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.
- Derived from this study: PubMed 34167318Wereski 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.
- Derived from this study: PubMed 32516805Hung 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.
- Derived from this study: PubMed 31623760Lee 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.
- Derived from this study: PubMed 31587565Chapman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas L Mills, MD, PhD principal investigator
University of Edinburgh
Ian Ford, PhD study chair
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-sensitivity troponin I assay in people with Acute Coronary Syndrome and Myocardial Infarction, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent myocardial infarction or cardiovascular death at 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01852123, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.