Suspected cardiac chest pain in the emergency department
| ISRCTN | ISRCTN20029061 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20029061 |
| IRAS number | 316000 |
| Secondary identifying numbers | CPMS 53789, IRAS 316000 |
- Submission date
- 21/04/2023
- Registration date
- 04/05/2023
- Last edited
- 24/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
This study will examine Emergency Department (ED) rule-out strategies for patients presenting with suspected cardiac chest pain. The study aims to understand how the use of blood tests and investigation strategies impacts a patient’s time in the ED. The study will also collect data on the final diagnoses of patients presenting to the ED with suspected cardiac chest pain, whether that be cardiac or non-cardiac in origin.
Who can participate?
Patients over the age of 18 years old attending the ED who require testing for suspected cardiac chest pain
What does the study involve?
The study involves no change to the tests carried out or treatment received. It involves the collection of information that is recorded as part of the routine care provided to the relevant patients.
What are the possible benefits and risks of participating?
There is no direct benefit to participants from their data being included in this study. There is potential for future benefit if the findings are used to better inform the healthcare delivery or management and investigation of suspected cardiac chest pain.
As there is no change to tests or treatment as part of the study, and all information used is recorded as part of routine clinical care, there is no additional risk to participants in terms of the care they receive. There are small privacy and confidentiality risks that are addressed in the manner in which data is collected and stored.
Where is the study run from?
The study is sponsored by North Bristol NHS Trust (UK). It is led by the UK Royal College of Emergency Medicine (RCEM) Trainee Emergency Research Network (TERN). The chief investigator for the study is based at the University of Bristol (UK)
When is the study starting and how long is it expected to run for?
March 2022 to May 2023
Who is funding the study?
Royal College of Emergency Medicine (RCEM).
Who is the main contact?
Dr Fraser Birse (TERN Fellow), tern@rcem.ac.uk
Contact information
Principal Investigator
North Bristol NHS Trust
Southmead Hospital
Southmead Road
Bristol
BS10 5NB
United Kingdom
| Phone | +44(0)117 4145101 |
|---|---|
| ed.carlton@nbt.nhs.uk |
Public
Study team
Bristol
None available
United Kingdom
| Phone | None available |
|---|---|
| tern@rcem.ac.uk |
Principal Investigator
North Bristol NHS Trust
Work Address Southmead Hospital
Southmead Road
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0002-2064-4618 |
|---|---|
| Phone | +44 (0)117414 5101 |
| Ed.Carlton@nbt.nhs.uk |
Study information
| Study design | Prospective multi-centre observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Medical and other records |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Acute coronary syndrome rule-out strategies in the emergency department: An observational evaluation of current UK practice & clinical effectiveness |
| Study acronym | ACS:ED |
| Study objectives | This is an observational study. Our overall aim is to establish the clinical effectiveness of different ACS investigation strategies across EDs in the UK, the epidemiology of ACS across the UK, and the different investigation strategies these EDs use. |
| Ethics approval(s) | Approved 29/09/2022, Health and Care Research Wales (4, 15-19 Cowbridge Road East, Castlebridge, Cardiff, CF11 9AB, UK; +44 (0)29 2023 0457; Wales.REC3@wales.nhs.uk), ref: 22/WA/0247 |
| Health condition(s) or problem(s) studied | Ischaemic heart diseases |
| Intervention | This study is a prospective multi-centre observational study that will be conducted across a ten-week period starting in March 2023. Patients will be actively recruited over a period of 7 days chosen by each site within a six-week window. A cross-sectional survey will also be administered to all recruiting hospitals collecting data on their local ACS rule-out strategies. Participants: Consecutive adult (18 years or above) patients presenting to the ED with suspected cardiac chest pain who trigger testing to diagnose or exclude a suspected cardiac cause for their chest pain will be recruited. Patients with another medical condition requiring hospital admission, prisoners presenting to ED, non-English speakers for whom the translation is unable to be offered, and those with a clear non-ACS cause at presentation will be excluded. Data collection: Patients will be identified prospectively but, depending on resource availability, may be collected retrospectively. Data collection will be performed by clinicians or research teams where these are present. To maximise the generalisability of the study but minimize the administrative burden, the team decided to use an opt-out consent process to facilitate recruitment into the trial. Demographic data and pathway-specific parameters will be collected at the point of clinical review on digitised case report forms (CRF). Research nurse or clinician follow-up using clinical notes or electronic health records will be conducted to document reference standard ED diagnosis and clinical outcome including acute myocardial infarction (AMI). Patient data collected will focus on pathway performance, including patient demographics, length of stay in ED +/- observation ward, ED disposition and discharge diagnosis, as well as information on biochemical markers and patient-risk category for ACS as assessed by the risk-stratification strategy used at each ED. Data will be collected separately from each site about their use of biochemical assays, reference ranges, use of ACS rule-out strategy and pathway for investigation of these patients. After the patient has been discharged from the ED or observation unit subsequent relevant investigations performed within 28 days will be followed up. |
| Intervention type | Other |
| Primary outcome measure | 1. Index acute myocardial infarction rate measured using coded diagnosis and assessment of troponin results and ECG changes at discharge from hospital 2. Length of stay in the emergency department +/- observation ward measured in minutes at presentation/baseline 3. ACS risk stratification strategy used, and patient risk category measured using the risk category as per stratification tool used at each site eg. very low/low/moderate/high at presentation/baseline |
| Secondary outcome measures | 1. Time to be seen by the treating clinician measured in minutes at presentation/baseline 2. Emergency department disposition measured at the discharge destination at discharge from the emergency department 3. Discharge diagnosis measured using coded discharge diagnosis at discharge from hospital |
| Overall study start date | 01/03/2022 |
| Completion date | 29/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 5460; UK Sample Size: 5460 |
| Total final enrolment | 8621 |
| Key inclusion criteria | 1. All adult patients (> = 18 years of age) presenting to the ED with chest pain who trigger testing to rule-in or rule-out a cardiac cause |
| Key exclusion criteria | 1. Patients with another medical condition requiring hospital admission 2. Clear non-ACS cause at presentation 3. Prisoner presenting to ED 4. Non-English speakers where translation is unable to be offered |
| Date of first enrolment | 13/03/2023 |
| Date of final enrolment | 23/04/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Sponsor information
Hospital/treatment centre
C/o: Helen Lewis-White
Level 3 Learning & Research Building
Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0)117 4149330 |
|---|---|
| ResearchSponsor@nbt.nhs.uk | |
| Website | http://www.nbt.nhs.uk/ |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- RCEM
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The results from this study will be submitted for publication in leading journals and to national conferences for presentation. We will aim to do this by May 2024. The Trainee Emergency Research Network’s (TERN’s) work with RCEMLearning has generated a focal point for knowledge dissemination in the UK. Using social media and TERN’s email list, TERN will publish a multitude of blogs, infographics and podcasts to supplement a publication, which will be hosted on RCEMLearning. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository, REDCap, https://www.project-redcap.org/. The type of data stored will be: Date of birth; Ethnicity; Sex; Length of stay; Investigation results; and, Discharge diagnosis. The process for requesting access is to contact the central study team via tern@rcem.ac.uk. Timing for availability to be decided if any requests are received. This study is using opt-out consent. Data is pseudo-anonymised at the point of entry to the central study database. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.4 | 31/01/2023 | 26/04/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 18/06/2025 | 24/06/2025 | Yes | No |
Additional files
Editorial Notes
24/06/2025: Publication reference added.
18/06/2024: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The intention to publish date was changed from 30/05/2024 to 30/09/2024.
05/05/2023: Internal review.
21/04/2023: Trial's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
