Sixth Generation High-sensitivity Cardiac Troponin T for the Early Rule Out of Myocardial Infarction: a Controlled Before and After Study
STEREO-MI
1 other identifier
interventional
19,500
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Typical duration for not_applicable
3 active sites
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
May 22, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
June 9, 2026
May 1, 2026
1.9 years
May 22, 2026
June 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
From Emergency Department arrival until Emergency Department discharge or hospital admission, up to 7 days
Secondary Outcomes (19)
Length of hospital stay
From initial presentation until hospital discharge, up to 1 year
Hospital admission
From initial presentation to the Emergency Department up to 7 days
Serial cardiac troponin measurements
From initial presentation until hospital discharge, up to 1 year
Cardiovascular death at 30 days
From initial presentation until 30 days after initial presentation
Cardiovascular death at 1 year
From initial presentation until 1 year after initial presentation
- +14 more secondary outcomes
Study Arms (2)
Pre-implementation
ACTIVE 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
Post-implementation
EXPERIMENTALConsecutive 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Insufficient clinical information to perform record linkage.
- Not resident in Scotland.
- Previous enrolment in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- Roche Diagnostic Ltd.collaborator
Study Sites (3)
The Royal Infirmary of Edinburgh
Edinburgh, Midlothian, EH16 4SA, United Kingdom
Western General Hospital
Edinburgh, Midlothian, EH4 2XU, United Kingdom
St. John's Hospital
Livingston, West Lothian, EH54 6PP, United Kingdom
Related Publications (2)
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.
PMID: 41405901BACKGROUNDThurston 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 Apr 22:e260477. doi: 10.1001/jamacardio.2026.0477. Online ahead of print.
PMID: 42018311BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew R Chapman, MD PhD
University of Edinburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2026
First Posted
June 9, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2029
Last Updated
June 9, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- From study conclusion for 5 years
- Access Criteria
- Access is contingent on a project application to DataLoch that fulfils key governance criteria on independent review. Further details may be obtained by contacting dataloch@ed.ac.uk
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)