Is the Current Threshold for Diagnosis of Abnormality, Including Non ST Elevation Myocardial Infarction, Using Raised Highly Sensitive Troponin Appropriate for a Hospital Population? The CHARIOT Study

Study Overview
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Brief Summary
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Currently when defining the upper limit of normal (ULN) or 99th percentile of a troponin assay manufacturer's use a healthy population traditionally aged 18-40. The 99th percentile value is the recommended value to use when diagnosing patients with an acute myocardial infarction. With the advent of the new highly sensitive troponin assays it has become clear that many patients have a troponin level above the 99th percentile when they have not suffered a myocardial infarction. We believe part of the problem with interpreting the the troponin values for patients is that the 99th percentile value which determines the ULN has been derived from population that is very different to the hospital population of patients. This study aims to demonstrate what the 99th percentile is for the population of people who use the hospital services who are traditionally older and have more comorbidities when compared to the population traditionally used to define the 99th percentile of a troponin assay. An amendment was approved to follow-up patients' clinical outcomes at 1 year using NHS Digital data.

Official Title
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Is the Current Threshold for Diagnosis of Abnormality, Including Non ST Elevation Myocardial Infarction, Using Raised Highly Sensitive Troponin Appropriate for a Hospital Population? The CHARIOT Study

Conditions
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Myocardial Infarction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (aged 18 years or older). Biochemistry blood sample already taken as part of routine clinical care. Exclusion Criteria: Individuals aged less than 18 years old. No biochemistry blood sample taken as part of routine clinical care. Biochemistry samples requested by General Practitioner

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospital population<br>All patients who have had a biochemistry blood tests requested at the trust will have a troponin blood level determined. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 99th percentile for the hospital population. | Distribution and 99th centile for hsTnI BC assay in 20000 consecutive patients having a biochemistry blood test at a large teaching hospital | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 99th percentile in different variables. | Distribution and 99th centile for hsTnI BC assay in: Outpatients versus inpatients Age by quintiles Female vs male ITU General medicine inpatients: chest infection/exacerbation of COPD/PE/DVT/overdose etc Emergency department, stratified by final diagnosis General surgery Major vascular surgery Major abdominal surgery Orthopaedic surgery… particularly fractured neck of femur and mortality outcome Brain surgery Rheumatoid outpatients according to level of disease activity Autoimmune disease inpatients and outpatients Inflammatory bowel disease inpatients & outpatients COPD inpatients & outpatients Diabetic outpatients and inpatients Dermatology outpatients according to activity of disease (psoriasis/pemphigus etc) | 6 months | 
| The 99th percentile in different variables. | Mortality | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction, Highly sensitive troponin, Hospital population, 99th percentile, Upper limit of normal