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NCT Number: NCT07636642

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Infirmary of Edinburgh, Edinburgh, Midlothian, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

sixth-generation high sensitivity cardiac troponin T assay

Diagnostic Test

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.

Other names: Troponin T high sensitivity generation six, TnT hs Gen 6

fifth-generation high sensitivity cardiac troponin T assay

Diagnostic Test

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.

Other names: Troponin T gen 5

Primary outcomes

  1. Length of stay within the Emergency Department

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

    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.

Secondary outcomes

  1. Length of hospital stay

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

    Total length of hospital stay from presentation until discharge from hospital

  2. Hospital admission

    Time frame: From initial presentation to the Emergency Department up to 7 days

    Admission to hospital during index presentation

  3. Serial cardiac troponin measurements

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

    Number of serial cardiac troponin measurements during index admission

  4. Cardiovascular death at 30 days

    Time frame: From initial presentation until 30 days after initial presentation

    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)

  5. Cardiovascular death at 1 year

    Time frame: From initial presentation until 1 year after initial presentation

    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)

  6. Myocardial infarction after discharge at 30 days

    Time frame: From initial hospital discharge until 30 days following index presentation

    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)

  7. Myocardial infarction after discharge at 1 year

    Time frame: From initial hospital discharge until 1 year following index presentation

    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)

  8. Reattendance with suspected myocardial infarction at 30 days

    Time frame: From initial hospital discharge until 30 days following initial presentation.

    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.

  9. Reattendance with suspected myocardial infarction at 1 year

    Time frame: From initial hospital discharge until 1 year following initial presentation.

    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.

  10. Unscheduled coronary revascularisation at 30 days

    Time frame: From initial hospital discharge until 30 days following initial presentation

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

  11. Unscheduled coronary revascularisation at 1 year

    Time frame: From initial hospital discharge until 1 year following initial presentation

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

  12. Hospitalisation due to heart failure at 30 days

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

    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.

  13. Hospitalisation due to heart failure at 1 year

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

    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.

  14. Death at 30 days

    Time frame: From initial presentation until 30 days

    Death due to any cause

  15. Death at 1 year

    Time frame: From initial presentation until 1 year

    Death due to any cause

  16. Myocardial injury

    Time frame: From initial presentation to hospital until 24 hours after presentation.

    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.

  17. Index myocardial infarction

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

    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

  18. Coronary angiography within 30 days

    Time frame: From initial presentation until 30 days later

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

  19. Time until initial troponin test

    Time frame: From initial presentation to hospital until 24 hours after presentation.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew R Chapman, MD PhD

CONTACT

[email protected]

+44131 242 6200

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Roche Diagnostic Ltd.

Registry information

Acronym: STEREO-MI

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 9, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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