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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-29

Study Completion Date

2017-12-01

Brief Summary

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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

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Conditions

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Myocardial Infarction

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hospital population

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nick Curzen, BM, PhD

Role: PRINCIPAL_INVESTIGATOR

Southampton NHS Trust

Locations

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Southampton General Hospital

Southampton, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED

PMID: 30867154 (View on PubMed)

Other Identifiers

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RHM CAR0516

Identifier Type: -

Identifier Source: org_study_id