Myocardial Infarction
Conditions
Keywords
cardiac troponin, myocardial infarction, acute coronary syndrome, accelerated decision pathway, Troponin T high sensitivity generation six
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.
Interventions
DIAGNOSTIC_TESTsixth-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 precision and resistance to interference.
DIAGNOSTIC_TESTfifth-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.
Sponsors
University of Edinburgh
Roche Diagnostic Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective controlled before-and-after study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay within the Emergency Department | From Emergency Department arrival until Emergency Department discharge or hospital admission, up to 7 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | From initial presentation until hospital discharge, up to 1 year | Total length of hospital stay from presentation until discharge from hospital |
| Hospital admission | From initial presentation to the Emergency Department up to 7 days | Admission to hospital during index presentation |
| Serial cardiac troponin measurements | From initial presentation until hospital discharge, up to 1 year | Number of serial cardiac troponin measurements during index admission |
| Cardiovascular death at 30 days | From initial presentation until 30 days after initial presentation | 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) |
| Cardiovascular death at 1 year | From initial presentation until 1 year after initial presentation | 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) |
| Myocardial infarction after discharge at 30 days | From initial hospital discharge until 30 days following index presentation | 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) |
| Myocardial infarction after discharge at 1 year | From initial hospital discharge until 1 year following index presentation | 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) |
| Reattendance with suspected myocardial infarction at 30 days | From initial hospital discharge until 30 days following initial presentation. | 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. |
| Reattendance with suspected myocardial infarction at 1 year | From initial hospital discharge until 1 year following initial presentation. | 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. |
| Unscheduled coronary revascularisation at 30 days | From initial hospital discharge until 30 days following initial presentation | Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission. |
| Unscheduled coronary revascularisation at 1 year | From initial hospital discharge until 1 year following initial presentation | Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission. |
| Hospitalisation due to heart failure at 30 days | From discharge from the initial hospital attendance until 30 days from initial presentation | 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. |
| Hospitalisation due to heart failure at 1 year | From discharge from the initial hospital attendance until 1 year from initial presentation | 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. |
| Death at 30 days | From initial presentation until 30 days | Death due to any cause |
| Death at 1 year | From initial presentation until 1 year | Death due to any cause |
| Myocardial injury | From initial presentation to hospital until 24 hours after presentation. | 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. |
| Index myocardial infarction | From initial presentation until hospital discharge, up to 1 year | 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 |
| Coronary angiography within 30 days | From initial presentation until 30 days later | Invasive coronary angiography performed within 30 days of the initial presentation to hospital. |
| Time until initial troponin test | From initial presentation to hospital until 24 hours after presentation. | Time from the arrival in the Emergency Department until collection of the first high-sensitivity cardiac troponin test. |
Countries
United Kingdom
Contacts
CONTACTAndrew R Chapman, MD PhD
PRINCIPAL_INVESTIGATORAndrew R Chapman, MD PhD
University of Edinburgh
Outcome results
None listed