AzTrials
AzTrials

Myocardial InfarctionSTEREO-MINCT07636642

Sixth Generation High-sensitivity Cardiac Troponin T for the Early Rule Out of Myocardial Infarction: a Controlled Before and After Study

A study testing sixth-generation high sensitivity cardiac troponin T assay and fifth-generation high sensitivity cardiac troponin T assay in people with Myocardial Infarction, run by University of Edinburgh at 3 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Cardiac troponin is a protein released into the blood when the heart muscle is damaged. Measuring this protein helps doctors diagnose a heart attack (also called a myocardial infarction). Modern blood tests, known as high-sensitivity cardiac troponin assays, can detect very small amounts of this protein. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
sixth-generation high sensitivity cardiac troponin T assay and fifth-generation high sensitivity cardiac troponin T assay
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19,500 participants
Where
3 sitesUnited Kingdom
Study dates
1 Jun 2026to May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years and over.
  • Attending clinician suspects acute coronary syndrome.
  • At least one measurement of cardiac troponin using the Gen 5 or Gen 6 hs-cTnT assay.

Who cannot join

  • Insufficient clinical information to perform record linkage.
  • Not resident in Scotland.
  • Previous enrolment in the study.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Andrew R Chapman, MD PhD contact

+44131 242 6200

a.r.chapman@ed.ac.uk

United Kingdom3 sites, 3 recruiting
  • The Royal Infirmary of Edinburgh

    Edinburgh, Midlothian, EH16 4SA

    Andrew R Chapman, MD PhD, +44131 242 6200, a.r.chapman@ed.ac.uk

    Andrew R Chapman, MD PhD

    Recruiting
  • Western General Hospital

    Edinburgh, Midlothian, EH4 2XU

    Andrew R Chapman, MD PhD, +44131 242 6200, a.r.chapman@ed.ac.uk

    Andrew R Chapman, MD PhD

    Recruiting
  • St. John's Hospital

    Livingston, West Lothian, EH54 6PP

    Andrew R Chapman, MD PhD, +44131 242 6200, a.r.chapman@ed.ac.uk

    Andrew R Chapman, MD PhD

    Recruiting

Other trials in United Kingdom

About this study

Cardiac troponin is a protein released into the blood when the heart muscle is damaged. Measuring this protein helps doctors diagnose a heart attack (also called a myocardial infarction). Modern blood tests, known as high-sensitivity cardiac troponin assays, can detect very small amounts of this protein.

A new version of this test, called Troponin T high-sensitivity Gen 6, has recently been developed and approved for use. It is designed to be more accurate and reliable, detecting smaller changes in troponin levels and being less affected by technical interference. The investigators believe this improved test will allow doctors to diagnose heart attacks more quickly and decide sooner who needs to stay in hospital and who can safely go home. This could help reduce overcrowding in Accident and Emergency (A\&E) departments, a major challenge for the NHS.

Read more

This study will examine whether switching to this new test across a health board shortens the time patients with suspected heart attacks spend in the Emergency Department. The investigators will use information from the DataLoch Heart Disease Registry, which automatically collects anonymised hospital data for patients attending with possible heart attacks. The investigators will compare data from one year before and one year after implementation to see whether average length of stay changes and to confirm that patient safety remains high. This investigators will also measure both the current and new versions of the troponin test in surplus blood samples collected during two six-month periods-one before and one after the new test is introduced. This will allows the investigators to directly compare the two tests reliably.

Patients will not need to do anything extra to take part - the study uses information and samples already collected as part of their usual care.

Being tested
sixth-generation high sensitivity cardiac troponin T assay, fifth-generation high sensitivity cardiac troponin T assay
Keywords
cardiac troponin, myocardial infarction, acute coronary syndrome, accelerated decision pathway, Troponin T high sensitivity generation six
Medical subject headings
Myocardial Infarction, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sixth-generation high sensitivity cardiac troponin T assayDiagnostic test

    Also called Troponin T high sensitivity generation six, TnT hs Gen 6

    Elecsys Troponin T hs Gen 6 is an immunoassay for the in vitro quantitative determination of cardiac troponin T in human serum and plasma, that can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g. acute myocardial infarction (AMI). In contrast to the previous generation of the assay (Elecsys Troponin T hs), the Gen 6 assay has been standardised against recombinant human cardiac troponin T, and has been demonstrated to have greater analytical precision and resistance to interference.

  • fifth-generation high sensitivity cardiac troponin T assayDiagnostic test

    Also called Troponin T gen 5

    Elecsys Troponin T Gen 5 is an immunoassay for the in vitro quantitative determination of cardiac troponin T in human serum and plasma, that can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g. acute myocardial infarction (AMI). It is the most widely used high-sensitivity troponin assay globally.

Study groups in NCT07636642
Study groupRoleWhat they receive
Pre-implementationActive comparatorConsecutive patients presenting with suspected acute coronary syndrome for 12 months prior to the implementation of the sixth generation hs-cTnT assay will be enrolled into the "pre-implementation" arm, where care is guided by the current, fifth-generation assay
Receives: Diagnostic Test: fifth-generation high sensitivity cardiac troponin T assay
Post-implementationExperimentalConsecutive patients presenting with suspected acute coronary syndrome for 12 months after the implementation of the sixth generation hs-cTnT assay will be enrolled into the "post-implementation" arm, where care is guided by the sixth-generation assay
Receives: Diagnostic Test: sixth-generation high sensitivity cardiac troponin T assay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of stay within the Emergency Department

    Length of stay within the Emergency Department, defined as the time from arrival until discharge from the Emergency Department or referral for admission to hospital.

    Measured: From Emergency Department arrival until Emergency Department discharge or hospital admission, up to 7 days

Secondary outcomes (19)
  1. Length of hospital stay

    Total length of hospital stay from presentation until discharge from hospital

    Measured: From initial presentation until hospital discharge, up to 1 year

  2. Hospital admission

    Admission to hospital during index presentation

    Measured: From initial presentation to the Emergency Department up to 7 days

  3. Serial cardiac troponin measurements

    Number of serial cardiac troponin measurements during index admission

    Measured: From initial presentation until hospital discharge, up to 1 year

  4. Cardiovascular death at 30 days

    Cardiovascular death at 30 days following presentation defined according to the Standardized Data Collection for Cardiovascular Trials Initiative: deaths that result from an AMI, sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to CV procedures, death due to CV hemorrhage, and death due to other CV causes (ICD10 codes I00-I99, limited to positions 1 or 2 in the record of death)

    Measured: From initial presentation until 30 days after initial presentation

  5. Cardiovascular death at 1 year

    Cardiovascular death at 30 days following presentation defined according to the Standardized Data Collection for Cardiovascular Trials Initiative: deaths that result from an AMI, sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to CV procedures, death due to CV hemorrhage, and death due to other CV causes (ICD10 codes I00-I99, limited to positions 1 or 2 in the record of death)

    Measured: From initial presentation until 1 year after initial presentation

  6. Myocardial infarction after discharge at 30 days

    Myocardial infarction following discharge from hospital at 30 days (a hospital episode recorded in the Scottish Morbidity Record associated with ICD10 codes I21 or I22, limited to position 1 or 2 on the discharge list)

    Measured: From initial hospital discharge until 30 days following index presentation

  7. Myocardial infarction after discharge at 1 year

    Myocardial infarction following discharge from hospital at 30 days (a hospital episode recorded in the Scottish Morbidity Record associated with ICD10 codes I21 or I22, limited to position 1 or 2 on the discharge list)

    Measured: From initial hospital discharge until 1 year following index presentation

  8. Reattendance with suspected myocardial infarction at 30 days

    A subsequent attendance to an Emergency Department or Acute Medical Unit during which a clinician responsible for care requests measurement of cardiac troponin for suspected acute coronary syndrome.

    Measured: From initial hospital discharge until 30 days following initial presentation.

  9. Reattendance with suspected myocardial infarction at 1 year

    A subsequent attendance to an Emergency Department or Acute Medical Unit during which a clinician responsible for care requests measurement of cardiac troponin for suspected acute coronary syndrome.

    Measured: From initial hospital discharge until 1 year following initial presentation.

  10. Unscheduled coronary revascularisation at 30 days

    Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission.

    Measured: From initial hospital discharge until 30 days following initial presentation

  11. Unscheduled coronary revascularisation at 1 year

    Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission.

    Measured: From initial hospital discharge until 1 year following initial presentation

  12. Hospitalisation due to heart failure at 30 days

    A hospital episode recorded in the Scottish Morbidity Record associated with ICD10 code I25.5 or I50, limited to position 1 or 2 on the discharge list.

    Measured: From discharge from the initial hospital attendance until 30 days from initial presentation

  13. Hospitalisation due to heart failure at 1 year

    A hospital episode recorded in the Scottish Morbidity Record associated with ICD10 code I25.5 or I50, limited to position 1 or 2 on the discharge list.

    Measured: From discharge from the initial hospital attendance until 1 year from initial presentation

  14. Death at 30 days

    Death due to any cause

    Measured: From initial presentation until 30 days

  15. Death at 1 year

    Death due to any cause

    Measured: From initial presentation until 1 year

  16. Myocardial injury

    Any cardiac troponin measurement above the sex-specific 99th percentile upper reference limit of the relevant assay, during the first 24 hours of the initial presentation to hospital.

    Measured: From initial presentation to hospital until 24 hours after presentation.

  17. Index myocardial infarction

    Myocardial infarction during the index presentation to hospital (ICD10 codes I21 or I22 associated with the episode in the Scottish Morbidity Record, restricted to position 1 or 2

    Measured: From initial presentation until hospital discharge, up to 1 year

  18. Coronary angiography within 30 days

    Invasive coronary angiography performed within 30 days of the initial presentation to hospital.

    Measured: From initial presentation until 30 days later

  19. Time until initial troponin test

    Time from the arrival in the Emergency Department until collection of the first high-sensitivity cardiac troponin test.

    Measured: From initial presentation to hospital until 24 hours after presentation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start1 Jun 2026
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Model description
Prospective controlled before-and-after study
Masking
None (open label)
Enrolment
19,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07636642
Sponsor's protocol ID
AC25189
Acronym
STEREO-MI
Status last verified
Jul 2026
First submitted
22 May 2026
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The individual data underlying the study can be made available via a Secure Data Environment to approved researchers on application to DataLoch (dataloch@ed.ac.uk)

Publications

  • 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.

    PubMed 41405901
  • Thurston AJF, Tew YY, Lopez-Ayala P, Koechlin L, O'Brien R, Lynch S, Cooper JG, Fujisawa T, Bima P, McDermott M, Tuck C, Mizerska M, Highton-Williamson E, McCurrach F, Lowry MTH, Doudesis D, Anand A, Lee KK, Ferry AV, Chapman A, Newby DE, Boeddinghaus J, Mueller C, Gray AJ, Mills NL; POC-ET and APACE Investigators. Early Rule Out of Myocardial Infarction With a Novel High-Sensitivity Cardiac Troponin T Assay. JAMA Cardiol. 2026 Jun 1;11(6):583-592. doi: 10.1001/jamacardio.2026.0477.

    PubMed 42018311

Questions about this trial

What is this clinical trial studying?

A study testing sixth-generation high sensitivity cardiac troponin T assay and fifth-generation high sensitivity cardiac troponin T assay in people with Myocardial Infarction, run by University of Edinburgh at 3 sites 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrew R Chapman, MD PhD (+44131 242 6200, a.r.chapman@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of stay within the Emergency Department (time frame: From Emergency Department arrival until Emergency Department discharge or hospital admission, up to 7 days). 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 NCT07636642, which also lists 2 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 7 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in