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

Myocardial Infarction Clinical Trial

— CHARIOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047785
• Other study ID #: RHM CAR0516
• Status: Completed
• Start date: June 29, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: December 2020
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20000
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction

Locations

Country	Name	City	State
United Kingdom	Southampton General Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The 99th percentile in different variables.	Mortality	12 months