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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 (CHARIOT)

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ClinicalTrials.gov Identifier: NCT03047785
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

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.

Condition or disease
Myocardial Infarction

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Study Type : Observational
Actual Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 29, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Hospital population
All patients who have had a biochemistry blood tests requested at the trust will have a troponin blood level determined.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047785


Locations
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United Kingdom
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Investigators
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Principal Investigator: Nick Curzen, BM, PhD Southampton NHS Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03047785     History of Changes
Other Study ID Numbers: RHM CAR0516
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Southampton NHS Foundation Trust:
Myocardial Infarction
Highly sensitive troponin
Hospital population
99th percentile
Upper limit of normal
Additional relevant MeSH terms:
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Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Hypersensitivity
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Immune System Diseases