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

Overview

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.

Interventions

• Diagnostic test sixth-generation high sensitivity cardiac troponin T assay
  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 p
• Diagnostic test fifth-generation high sensitivity cardiac troponin T assay
  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.

Primary outcome measures

• Length of stay within the Emergency Department [Time frame: From Emergency Department arrival until Emergency Department discharge or hospital admission, up to 7 days]

Secondary outcome measures (12)

• Length of hospital stay [Time frame: From initial presentation until hospital discharge, up to 1 year]
• Hospital admission [Time frame: From initial presentation to the Emergency Department up to 7 days]
• Serial cardiac troponin measurements [Time frame: From initial presentation until hospital discharge, up to 1 year]
• Cardiovascular death at 30 days [Time frame: From initial presentation until 30 days after initial presentation]
• Cardiovascular death at 1 year [Time frame: From initial presentation until 1 year after initial presentation]
• Myocardial infarction after discharge at 30 days [Time frame: From initial hospital discharge until 30 days following index presentation]
• Myocardial infarction after discharge at 1 year [Time frame: From initial hospital discharge until 1 year following index presentation]
• Reattendance with suspected myocardial infarction at 30 days [Time frame: From initial hospital discharge until 30 days following initial presentation.]
• Reattendance with suspected myocardial infarction at 1 year [Time frame: From initial hospital discharge until 1 year following initial presentation.]
• Unscheduled coronary revascularisation at 30 days [Time frame: From initial hospital discharge until 30 days following initial presentation]
• Unscheduled coronary revascularisation at 1 year [Time frame: From initial hospital discharge until 1 year following initial presentation]
• Hospitalisation due to heart failure at 30 days [Time frame: From discharge from the initial hospital attendance until 30 days from initial presentation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Diagnostic

Study locations

United Kingdom · 3 centers

• The Royal Infirmary of Edinburgh — Edinburgh
• Western General Hospital — Edinburgh
• St. John's Hospital — Livingston

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. 20 PMID 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 Tropo PMID 42018311

Identifiers

NCT: NCT07636642 · AC25189

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗