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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
19,500
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.
The Royal Infirmary of Edinburgh
Edinburgh, Midlothian, United Kingdom
Western General Hospital
Edinburgh, Midlothian, United Kingdom
St. John's Hospital
Livingston, West Lothian, United Kingdom
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
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
Hospital admission
Admission to hospital during index presentation
Time frame: From initial presentation to the Emergency Department up to 7 days
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
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
Cardiovascular death at 1 year
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 1 year after initial presentation
Myocardial infarction after discharge at 30 days
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)
Time frame: From initial hospital discharge until 30 days following index presentation
Myocardial infarction after discharge at 1 year
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)
Time frame: From initial hospital discharge until 1 year following index presentation
Reattendance with suspected myocardial infarction at 30 days
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.
Time frame: From initial hospital discharge until 30 days following initial presentation.
Reattendance with suspected myocardial infarction at 1 year
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.
Time frame: From initial hospital discharge until 1 year following initial presentation.
Unscheduled coronary revascularisation at 30 days
Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission.
Time frame: From initial hospital discharge until 30 days following initial presentation
Unscheduled coronary revascularisation at 1 year
Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission.
Time frame: From initial hospital discharge until 1 year following initial presentation
Hospitalisation due to heart failure at 30 days
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.
Time frame: From discharge from the initial hospital attendance until 30 days from initial presentation
Hospitalisation due to heart failure at 1 year
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.
Time frame: From discharge from the initial hospital attendance until 1 year from initial presentation
Death at 30 days
Death due to any cause
Time frame: From initial presentation until 30 days
Death at 1 year
Death due to any cause
Time frame: From initial presentation until 1 year
Myocardial injury
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.
Time frame: From initial presentation to hospital until 24 hours after presentation.
Index myocardial infarction
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
Time frame: From initial presentation until hospital discharge, up to 1 year
Coronary angiography within 30 days
Invasive coronary angiography performed within 30 days of the initial presentation to hospital.
Time frame: From initial presentation until 30 days later
Time until initial troponin test
Time from the arrival in the Emergency Department until collection of the first high-sensitivity cardiac troponin test.
Time frame: From initial presentation to hospital until 24 hours after presentation.
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