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

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT03047785
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-09
• Study Start: 2017-06-29
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The 99th percentile for the hospital population.	6 months	Distribution and 99th centile for hsTnI BC assay in 20000 consecutive patients having a biochemistry blood test at a large teaching hospital

Secondary Outcome Measures

Name	Time	Method
The 99th percentile in different variables.	12 months	Mortality

Trial Locations

Locations (1)

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom