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Trial of switching high-sensitivity cardiac troponin assays in suspected acute coronary syndrome: an interrupted time series analysis (TWITCH-ED study)
Safe People
Organisation name
University of Edinburgh
Applicant name(s)
Jasper Boeddinghaus
Funders/ Sponsors
HDR UK British Heart Foundation
Safe Projects
Project ID
DL_2022_046
Lay summary
When the heart is damaged troponin is being released in the bloodstream. High-sensitivity troponin tests measure the troponin level in the blood and are the preferred choice for the diagnosis of a heart attack. In clinical practice either a high-sensitivity troponin I or T test is being used. They are both recommended in current guidelines, but limited data is available about the agreement between the diagnostic cut offs of high-sensitivity troponin I and T. NHS Lothian hospitals have changed from a high-sensitivity troponin I to a T test. As part of this process, it is standard laboratory practice for NHS Lothian to verify the performance of the new test. Therefore, we will evaluate in patients who present to the Emergency Department with a suspicion of a heart attack whether more patients are going to be hospitalised and the impact on cardiac investigations, care and clinical outcomes.
Public benefit statement
Cardiac troponin is central to the diagnosis of myocardial infarction and hs-cTn assays are preferred for the assessment of patients with suspected acute coronary syndrome. The 99th percentile upper reference limits of hs-cTn derived from a healthy reference population is the recommended diagnostic threshold for myocardial infarction. In October 2021, NHS Lothian hospitals (Royal Infirmary of Edinburgh, Western General Hospital, St John’s Hospital) have changed from a hs-cTnI assay to a hs-cTnT assay. Although both assays are recommended in current guidelines and are considered interchangeable, the impact of switching from a hs-cTnI assay to a hs-cTnT assay on clinical practice is unknown. At this point, no studies are available that have evaluated the impact of implementing European sex-specific hs-cTnT thresholds on subsequent events in routine health care. Whether the routine use of a hs-cTnT assay results in the identification of more patients with acute or chronic non-ischaemic myocardial injury is unknown, and the impact that discordant hs-cTnI and hs-cTnT concentrations have on clinical management and outcomes has not been systematically evaluated. Given this scenario occurs frequently, a systematic evaluation of the clinical impact of the transition from hs-cTnI to hs-cTnT on clinical practice would be informative for patients, physicians, and providers.
Request category type
Public Health Research
Other approval committees
Latest approval date
26/05/2023
Safe Data
Dataset(s) name
DataLoch Heart Disease Registry
Data sensitivity level
De-Personalised
Safe Setting
Access type
TRE