Suspected cardiac chest pain in the emergency department

ISRCTN	ISRCTN20029061
DOI	https://doi.org/10.1186/ISRCTN20029061
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	316000
Protocol serial number	CPMS 53789, IRAS 316000
Sponsor	North Bristol NHS Trust
Funder	Royal College of Emergency Medicine

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Edward Carlton
Principal investigator

North Bristol NHS Trust
Southmead Hospital
Southmead Road
Bristol
BS10 5NB
United Kingdom

Phone	+44(0)117 4145101
Email	ed.carlton@nbt.nhs.uk

Dr Fraser Birse
Public

Study team
Bristol
None available
United Kingdom

Phone	None available
Email	tern@rcem.ac.uk

Prof Edward Carlton
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
Email	Ed.Carlton@nbt.nhs.uk

Study information

Primary study design	Observational
Study design	Prospective multi-centre observational study
Secondary study design	Cohort study
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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
Completion date	29/05/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

North Bristol NHS Trust [Lead]

Southmead Hospital
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository
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?
Results article		18/06/2025	24/06/2025	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 2.4	31/01/2023	26/04/2023	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

43537_Protocol_V2.4_31Jan2023.pdf: Protocol file

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).