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 (CHARIOT)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction

• Study Type: Observational
• Enrollment (Actual): 20000

Contacts and Locations

Study Locations

• United Kingdom
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients (inpatients or outpatients) who have had a biochemistry sample requested by a hospital clinician as part of their routine clinical care. A total of 20,000 consecutive patients will be recruited.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hospital population; 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?

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

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Investigators: Principal Investigator: Nick Curzen, BM, PhD, Southampton NHS Trust

Publications and helpful links

General Publications

• Mariathas M, Allan R, Ramamoorthy S, Olechowski B, Hinton J, Azor M, Nicholas Z, Calver A, Corbett S, Mahmoudi M, Rawlins J, Simpson I, Wilkinson J, Kwok CS, Cook P, Mamas MA, Curzen N. True 99th centile of high sensitivity cardiac troponin for hospital patients: prospective, observational cohort study. BMJ. 2019 Mar 13;364:l729. doi: 10.1136/bmj.l729.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Myocardial Infarction; Highly sensitive troponin; Hospital population; 99th percentile; Upper limit of normal
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Myocardial Infarction; Infarction; Hypersensitivity; Non-ST Elevated Myocardial Infarction
• Other Study ID Numbers: RHM CAR0516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No