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

University Hospital Southampton NHS Foundation Trust

Status: Completed

Conditions: Myocardial Infarction

Study type: Observational

Funder types: Other

Identifiers

NCT03047785

RHM CAR0516

Details and patient eligibility

About

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.

Enrollment: 20,000 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20,000 participants in 1 patient group

Hospital population

Description:

All patients who have had a biochemistry blood tests requested at the trust will have a troponin blood level determined.