A bedside evaluation of a marker of heart injury in the blood
| ISRCTN | ISRCTN48377837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48377837 |
| IRAS number | 303373 |
| Secondary identifying numbers | IRAS 303373, CPMS 51536 |
- Submission date
- 01/06/2022
- Registration date
- 08/07/2022
- Last edited
- 21/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
When patients are admitted to a hospital with suspected heart attacks they have numerous blood tests over a number of hours before the diagnosis of a heart attack (acute myocardial infarction) can be excluded. The tests measure cardiac troponin, a marker of heart injury. Over the last decade, high-sensitivity cardiac troponin assays have been widely implemented and, by precisely detecting small concentrations of cardiac troponin, allow much faster diagnosis of heart attacks than was previously possible.
Point of care high-sensitivity cardiac troponin assays, which sensitively measure cardiac troponin levels within minutes at the patient's side, are now available. In this study, we will test the accuracy of new point-of-care high-sensitivity cardiac troponin assays for the diagnosis of acute myocardial infarction in the Emergency Department (ED).
Who can participate?
Adults presenting to the ED with chest pain or similar symptoms
What does the study involve?
In this study, we will ask consenting patients if they would donate blood samples for analysis in this research. We will draw blood on arrival and 1 hour later. The blood will be tested for levels of cardiac troponin using the new point of care assays. We will also collect data about the patient's symptoms and past history to see if using established risk scores and decision aids alongside the new troponin assays will improve diagnosis. Patients will undergo standard clinical assessment as part of the routine care and we will check if they have had any further cardiac events over the next 30 days by checking medical records +/- contacting the patient or their general practitioner, and an expert panel will determine whether the final diagnosis was acute myocardial infarction.
What are the possible benefits and risks of participating?
In some cases, the additional blood tests may cause some discomfort. In a small minority of cases, this may be complicated by bruising or discomfort at the site of venepuncture. Risks will be minimized by ensuring that trained members of staff undertake venepuncture. There is no direct benefit to their clinical care at the time of participating in the research. However, should the patient develop similar symptoms in the future, they may stand to benefit from the advances in diagnostic technology that may arise from this study.
Where is the study run from?
Manchester Royal Infirmary
When is the study starting and how long is it expected to run for?
December 2021 to December 2023
Who is funding the study?
Siemens Healthineers (Germany)
Who is the main contact?
Professor Richard Body, best.2study@mft.nhs.uk
Contact information
Public
Emerging Research Office
Manchester Royal Infirmary, Ground floor
Oxford Road
Manchester
M13 9WL
United Kingdom
| Phone | +44 (0)161 276 6777 |
|---|---|
| best.2study@mft.nhs.uk |
Study information
| Study design | Multicentre observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format |
| Scientific title | The second bedside evaluation of sensitive troponin (BEST-2) Study |
| Study acronym | BEST-2 |
| Study hypothesis | In patients presenting to the Emergency Department (ED) with suspected acute coronary syndromes (ACS), what is the diagnostic accuracy of the Siemens Atellica VTLi high-sensitivity cardiac troponin I assay when used, with and without decision aids that take account of a patient’s history and ECG, at the time of presentation and 1 hour later, for the target condition of acute myocardial infarction (AMI). |
| Ethics approval(s) | Approved 16/02/2022, East Midlands-Derby Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44(0)207 1048211; derby.rec@hra.nhs.uk), ref: 22/EM/0005 |
| Condition | Acute Coronary Syndromes |
| Intervention | An additional blood sample will be taken at the same time as routine sampling for the majority of patients. Some patients may require blood to be drawn after they have had routine blood samples. To minimise discomfort, where possible we will draw the sample from an indwelling intravenous cannula using aseptic technique. Participants will be followed up 30 days later via medical records and general practitioner, but possibly also patient contact. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Siemens Atellica VTLi high-sensitivity cardiac troponin I assay |
| Primary outcome measure | Diagnostic accuracy of the Siemens Atellica VTLi high-sensitivity cardiac troponin I assay, measured on arrival in the emergency department and 1 hour later using thresholds below the 99th percentile upper reference limit, for the target condition of acute myocardial infarction |
| Secondary outcome measures | 1. Incidence of major adverse cardiac events (MACE, cardiovascular death or AMI occurring within 30 days of enrolment), as measured by a review of medical records and/or GP questionnaire at 30 days 2. Incidence of coronary revascularization, as measured by review of medical records and/or GP questionnaire at 30 days 3. All-cause mortality, as measured by review of medical records and/or GP questionnaire at 30 days 4. Length of hospital stay, as measured by review of medical records and/or GP questionnaire at 30 days |
| Overall study start date | 03/12/2021 |
| Overall study end date | 07/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 700 |
| Total final enrolment | 720 |
| Participant inclusion criteria | 1. Aged 18 years or more 2. Presenting to the emergency department with a primary complaint of pain or discomfort in the chest, epigastrium, arm(s), jaw, neck or throat, which the treating clinician suspects may have been caused by an acute coronary syndrome |
| Participant exclusion criteria | 1. Overt ST-elevation myocardial infarction (STEMI) requiring immediate referral for coronary revascularization 2. Another reason requiring hospital admission, even if the diagnosis of acute coronary syndrome is excluded (e.g. arrhythmia, gastrointestinal bleeding, sepsis) 3. No symptoms in the previous 12 hours 4. No capacity, or unwillingness, to provide written informed consent |
| Recruitment start date | 01/07/2022 |
| Recruitment end date | 01/09/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Oxford Road
Manchester
M13 9WL
United Kingdom
London
E1 2ES
United Kingdom
London
NW1 2PG
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Tooting
London
SW17 0QT
United Kingdom
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Paisley
PA2 9PN
United Kingdom
Sponsor information
Hospital/treatment centre
First Floor
Nowgen building
Grafton street
Manchester
M13 9WU
England
United Kingdom
| Phone | +44 (0)161 276 4125 |
|---|---|
| research.sponsor@mft.nhs.uk | |
| Website | https://mft.nhs.uk/ |
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Siemens Healthineers AG
- Location
- Germany
Results and Publications
| Intention to publish date | 01/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed Journal, internal report, conference presentation, and publication on a website. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Richard Body richard.body@mft.nhs.uk. Anonymised data detailing the results of the index test and adjudicated final diagnosis will become available following peer-reviewed publication of the primary manuscript for 10 years. Anonymised data will be available upon request for anyone with an academic, non-commercial interest, subject to permission from the funder (Siemens Healthineers). Personal or potentially identifiable data and commercially sensitive data cannot be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/12/2023: The public contact has been changed.
12/12/2023: The following changes were made:
1. The overall study end date was changed from 01/12/2023 to 07/12/2023.
2. Siemens Atellica VTLi high-sensitivity cardiac troponin I assay was added as the drug/device/biological/vaccine name.
3. The total final enrolment was added.
03/04/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/04/2023 to 01/09/2023.
2. The intention to publish date was changed from 01/04/2024 to 01/09/2024.
3. The plain English summary was updated to reflect these changes.
4. The trial participating centre Royal Alexandra Hospital was added.
14/06/2022: Trial's existence confirmed by the East Midlands-Derby Research Ethics Committee, United Kingdom.
