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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Edinburgh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Insufficient clinical information to perform record linkage.

Not resident in Scotland.

Previous enrolment in the study.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

19,500 Participants
are divided into 2 treatment groups
Group A: Pre-implementationActive comparator 1 intervention
Group B: Post-implementationExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Length of hospital stay

Total length of hospital stay from presentation until discharge from hospital

Time frame
From initial presentation until hospital discharge, up to 1 year
2

Hospital admission

Admission to hospital during index presentation

Time frame
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

Time frame
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)

Time frame
From initial presentation until 30 days after initial presentation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Edinburgh

Lead sponsor

Roche Diagnostic Ltd.

Collaborator