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 volunteersQualifiers
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
Sequential
Treatments tested in this trial
sixth-generation high sensitivity cardiac troponin T assay
Diagnostic testElecsys 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 testElecsys 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Length of hospital stay
Total length of hospital stay from presentation until discharge from hospital
Hospital admission
Admission to hospital during index presentation
Serial cardiac troponin measurements
Number of serial cardiac troponin measurements during index admission
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)
Sponsors and contacts
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University of Edinburgh
Lead sponsor
Roche Diagnostic Ltd.
Collaborator