Myocardial InfarctionCHARIOTNCT03047785
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
An observational study of Myocardial Infarction, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- How many people
- 20,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jun 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adult patients (aged 18 years or older).
- Biochemistry blood sample already taken as part of routine clinical care.
Who cannot join
- Individuals aged less than 18 years old.
- No biochemistry blood sample taken as part of routine clinical care.
- Biochemistry samples requested by General Practitioner
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southampton General Hospital
Southampton, SO16 6YD
About this 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.
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Highly sensitive troponin, Hospital population, 99th percentile, Upper limit of normal
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospital population | All patients who have had a biochemistry blood tests requested at the trust will have a troponin blood level determined. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
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)
Measured: 6 months
The 99th percentile in different variables.
Mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start29 Jun 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Curzen, BM, PhD, Principal investigator, Southampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047785
- Sponsor's protocol ID
- RHM CAR0516
- Acronym
- CHARIOT
- Status last verified
- Dec 2020
- First submitted
- 8 Feb 2017
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30867154
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03047785
- Acronym / sponsor ID
- CHARIOT / RHM CAR0516
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Highly sensitive troponin, Hospital population, 99th percentile, Upper limit of normal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital population | – | –All patients who have had a biochemistry blood tests requested at the trust will have a troponin blood level determined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult patients (aged 18 years or older).
- Biochemistry blood sample already taken as part of routine clinical care.
Key exclusion criteria (3 listed)
- Individuals aged less than 18 years old.
- No biochemistry blood sample taken as part of routine clinical care.
- Biochemistry samples requested by General Practitioner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
The 99th percentile in different variables.
Time frame: 6 months
The 99th percentile in different variables.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Derived from this study: PubMed 30867154Mariathas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Curzen, BM, PhD principal investigator
Southampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 99th percentile for the hospital population. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.