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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The 99th percentile for the hospital population.

Time frame: 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 outcomes

The 99th percentile in different variables.

Time frame: 6 months
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)
The 99th percentile in different variables.

Time frame: 12 months

Mortality

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Registry information

Acronym: CHARIOT

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Feb 9, 2017
Registry last updated: Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed