Acute Coronary SyndromeTWITCH-EDNCT05748691
Switching From Cardiac Troponin I to T
An observational study of Acute Coronary Syndrome and Acute Myocardial Infarction, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Acute Myocardial Infarction, Acute Myocardial Ischemia
- What is being tested?
- Clinical implementation of hs-cTnT
- How many people
- 26,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2020to 25 Oct 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age 18 years and over
- Symptoms of possible acute coronary syndrome
- High-sensitivity cardiac troponin measured at presentation
Who cannot join
- Insufficient clinical information to perform record linkage
- Previous enrolment in the study
- Patients with ST-segment elevation myocardial infarction (STEMI)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Cardiovascular Science
Edinburgh, EH16 4SB
About this study
Official title: Trial of Switching High-sensitivity Cardiac Troponin Assays in Suspected Acute Coronary Syndrome: an Interrupted Time Series Analysis (TWITCH-ED Study)
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.
- Conditions
- Acute Coronary Syndrome, Acute Myocardial Infarction, Acute Myocardial Ischemia, Myocardial Injury, Chest Pain, Heart Failure
- Being tested
- Clinical implementation of hs-cTnT
- Keywords
- Acute Coronary Syndrome, Acute Myocardial Infarction, Myocardial Injury, High-Sensitivity Cardiac Troponin T, High-Sensitivity Cardiac Troponin I, Biomarker, Acute Cardiovascular Care, Diagnostic Pathways, Outcomes, Sex, Sex-specific Thresholds, Upper Reference Limits
- Medical subject headings
- Acute Coronary Syndrome, Chest Pain, Heart Failure, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical implementation of hs-cTnTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Clinical implementation of hs-cTnT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 24 hours
Secondary outcomes (14)
Proportion of patients with myocardial injury admitted to hospital
To determine the proportion of patients with myocardial injury admitted to hospital
Measured: Up to 24 hours
Length of hospital stay
To determine the length of hospital stay
Measured: Up to 30 days
Clinical diagnosis of myocardial infarction
To determine the prevalence of myocardial infarction
Measured: Up to 24 hours
Clinical diagnosis of heart failure
To determine the prevalence of heart failure
Measured: Up to 24 hours
Coronary angiography during hospital admission
To determine the number of coronary angiograms performed during hospital admission
Measured: Up to 30 days
Echocardiography during hospital admission
To determine the number of echocardiograms performed during hospital admission
Measured: 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
Measured: Up to 30 days
Revascularization at 30 days and one year
To determine the rate of coronary revascularization at 30 days and one year
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start25 Oct 2020
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 26,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748691
- Sponsor's protocol ID
- DL-2022-046
- Acronym
- TWITCH-ED
- Status last verified
- May 2024
- First submitted
- 9 Jan 2023
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30571511Shah 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.
PubMed 30170853Lee 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 31623760Mjoen 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.
PubMed 33585931Reichlin 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.
PubMed 23164485Shah 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 26454362Chapman 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.
PubMed 29127948Chapman 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.
PubMed 28034899Kimenai 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.
PubMed 29844245Apple 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.
PubMed 22983113Anand 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.
PubMed 30626631Collet 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.
PubMed 32860058Wildi 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.
PubMed 25948541Kimenai 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.
PubMed 27330150Mueller 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.
PubMed 30227114
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Switching High-sensitivity Cardiac Troponin Assays in Suspected Acute Coronary Syndrome: an Interrupted Time Series Analysis (TWITCH-ED Study)
- ClinicalTrials.gov ID
- NCT05748691
- Acronym / sponsor ID
- TWITCH-ED / DL-2022-046
- Conditions
- Acute Coronary Syndrome, Acute Myocardial Infarction, Acute Myocardial Ischemia, Myocardial Injury, Chest Pain, Heart Failure
- Keywords
- Acute Coronary Syndrome, Acute Myocardial Infarction, Myocardial Injury, High-Sensitivity Cardiac Troponin T, High-Sensitivity Cardiac Troponin I, Biomarker, Acute Cardiovascular Care, Diagnostic Pathways
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26,000 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 25 Oct 2020 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 1 Mar 2023 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation group | – | –Clinical use of hs-cTnI in patients with suspected acute coronary syndrome |
| Post-implementation group | – | Diagnostic Test: Clinical implementation of hs-cTnTClinical use of hs-cTnT in patients with suspected acute coronary syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Age 18 years and over
- Symptoms of possible acute coronary syndrome
- High-sensitivity cardiac troponin measured at presentation
Key exclusion criteria (3 listed)
- Insufficient clinical information to perform record linkage
- Previous enrolment in the study
- Patients with ST-segment elevation myocardial infarction (STEMI)
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 |
|---|---|---|
| Clinical implementation of hs-cTnTTo 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. | Diagnostic test | Post-implementation group |
Primary outcome
Proportion of patients with suspected acute coronary syndrome admitted to hospital
Time frame: Up to 24 hours
To determine the proportion of patients with and without myocardial injury admitted to the hospital before and after implementation of the hs-cTnT assay
14 secondary outcomes
Proportion of patients with myocardial injury admitted to hospital
Time frame: Up to 24 hours
Length of hospital stay
Time frame: Up to 30 days
Clinical diagnosis of myocardial infarction
Time frame: Up to 24 hours
Clinical diagnosis of heart failure
Time frame: Up to 24 hours
Coronary angiography during hospital admission
Time frame: Up to 30 days
Echocardiography during hospital admission
Time frame: Up to 30 days
New prescription of evidence-based treatment for coronary artery disease or heart failure following discharge
Time frame: Up to 30 days
Revascularization at 30 days and one year
Time frame: 30 days and 1 year
Reattendance with suspected acute coronary syndrome at 30 days and one year
Time frame: 30 days and 1 year
Subsequent myocardial infarction at 30 days and one year
Time frame: 30 days and 1 year
Subsequent heart failure at 30 days and one year
Time frame: 30 days and 1 year
Subsequent myocardial infarction, heart failure or cardiovascular death at 30 days and one year
Time frame: 30 days and 1 year
Cardiovascular death at 30 days and one year
Time frame: 30 days and 1 year
All-cause death at 30 days and one year
Time frame: 30 days and 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 28 May 2024.
- Background: PubMed 30571511Thygesen 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.
- Background: PubMed 30170853Shah 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.
- Background: 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.
- Background: PubMed 33585931Mjoen 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.
- Background: PubMed 23164485Reichlin 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.
- Background: 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.
- Background: PubMed 29127948Chapman 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.
- Background: PubMed 28034899Chapman 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.
- Background: PubMed 29844245Kimenai 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.
- Background: PubMed 22983113Apple 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.
- Background: PubMed 30626631Anand 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.
- Background: PubMed 32860058Collet 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Acute 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 3 inclusion and 3 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 28 May 2024. 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?
Proportion of patients with suspected acute coronary syndrome admitted to hospital (time frame: Up to 24 hours). 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 NCT05748691, 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 28 May 2024.