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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03047785
Acronym
CHARIOT
Enrollment
20000
Registered
2017-02-09
Start date
2017-06-29
Completion date
2017-12-01
Last updated
2020-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction, Highly sensitive troponin, Hospital population, 99th percentile, Upper limit of normal

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.

Interventions

None listed

Sponsors

University Hospital Southampton NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The 99th percentile for the hospital population.6 monthsDistribution and 99th centile for hsTnI BC assay in 20000 consecutive patients having a biochemistry blood test at a large teaching hospital

Secondary

MeasureTime frameDescription
The 99th percentile in different variables.6 monthsDistribution 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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026