Plain English Summary
Background and study aims
When people suffer from chest pain we are often worried that the pains may be coming from a heart problem such as a heart attack. It is often difficult to tell quickly if a patient has pain from a heart problem or from something less serious like a muscle strain. Unfortunately, current blood tests do not give accurate results until at least 12 hours after the chest pain started. This often means an anxious wait and a delay before treatment can start. To help with the problem, we have developed the Manchester Acute Coronary Syndromes (MACS) decision rule from research involving over 1,200 patients. This rule uses blood test results and clinical information collected by the doctor. This rule could identify quickly who has had a heart attack. Many people could be safely reassured that they have not had a heart attack and could go home, avoiding unnecessary hospital admission for further tests. The MACS decision rule also helps doctors to make accurate decisions about the most appropriate ward for patients who do need admission. Before using the rule in practice, we must determine whether using it in reality produces measurable benefit. This will require a large study at many centres across the country. Before starting on this, the aim is to run a smaller study that will find out the possibility of conducting such a large study.
Who can participate?
Adult patients who come to the Emergency Department with chest pain that doctors suspect may have been caused by a heart attack.
What does the study involve?
Participants are randomly allocated to either the usual care group or the MACS decision rule group. Those in the usual care group receive the usual care, with no changes. Where permission is granted, additional blood samples are taken from these participants when they arrive at the Emergency Department and 1 hour later. The samples are stored to be tested for markers of heart disease at a later date, to improve the quality of the tests for heart disease. Participants who are allocated to the MACS decision rule group have their care guided by the MACS decision rule. The initial tests may identify that it is safe for these participants to return home without hospital admission. If so, participants and doctors can still jointly decide whether this is the most appropriate course of action for the individual participant. The MACS decision rule also allocates participants to one of four risk groups, which the doctor can use to decide the best area of the hospital for the participant to be treated in. Participants who are discharged from hospital early because of the decision rule will be given a follow up appointment. This usually takes place on the following day, but can also be arranged for any time within the next 3 days. This allows staff to take an extra blood sample as an extra check that the participants heart has not suffered any damage. To find out about participants experiences of taking part in this study, some participants are invited to give a detailed account of their experiences either during a telephone interview or during a focus group interview with between 4 and 8 other participants. The interviews are recorded to make sure that important details are not missed. It is very important to know whether the people taking part in this study experience any further medical problems soon after discharge. Participants are therefore contacted by telephone, email, letter or even a home visit (whichever is most convenient) after 7 days, 30 days and 6 months. Finally, participants are sent a questionnaire through the post after 30 days, 3 months and 6 months to find out the details of any health problems they may have had and to work out the costs of those problems to the National Health Service (NHS).
What are the possible benefits and risks of participating?
The researchers cannot promise that taking part in this study will bring benefits to individual participants. It is possible that they will be able to return home sooner. If participants are invited and agree to take part in a focus group or a telephone interview to explore their experiences, they are offered a £10 high street voucher as a token of thanks and, if they have to travel to the hospital for this, travel and parking expenses are reimbursed. As the study does not involve changing the drugs that participants are taking, the risks of taking part are minimal. Previous research suggests that the risks of patients being discharged with an undetected heart attack are extremely small. If participants do go home earlier than usual, they are given an early appointment for a further blood test. If they did have a heart attack that had not previously been detected, it will be picked up by this blood test. If a heart attack is detected, participants will still receive all the appropriate treatment. In very rare cases, taking blood can lead to prolonged bleeding, bruising, accidental damage to the blood vessels and/or infections. However, all blood samples will be drawn by experienced staff members who have received appropriate training. The small amount of blood taken will not have any harmful effects for the participants.
Where is the study run from?
The study is sponsored by Central Manchester University Hospitals NHS Foundation Trust (UK) and will take place at Manchester Royal Infirmary and Salford Royal Hospital (UK).
When is study starting and how long is it expected to run for?
August 2013 to February 2014
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Richard Body
richard.body@cmft.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Richard Body
ORCID ID
Contact details
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 8539
richard.body@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14334
Study information
Scientific title
Reducing unnecessary admissions for chest pain with the Manchester Acute Coronary Syndromes (MACS) decision rule: feasibility study
Acronym
MACS
Study hypothesis
The aim of this study is to evaluate the feasibility of a multicentre randomised controlled trial to evaluate whether use of the MACS clinical decision rule can safely reduce unnecessary hospital admissions for suspected cardiac chest pain.
Ethics approval
21/03/2013, ref: 13/NW/0081
Study design
Randomised; Interventional; Design type: Diagnosis, Not specified
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Cardiovascular, Injuries and Emergencies; Subtopic: Cardiovascular (all Subtopics), Injuries and Emergencies (all Subtopics); Disease: Injuries and Emergencies, Congenital Heart Disease and Pulmonary Hypertension
Intervention
1. Control Group: Care of the control group will be guided by local Emergency Department guidelines for the management of suspected cardiac chest pain, which are compliant with current national and international guidance.
2. The intervention group: MACS Decision Rule. This group will have their care in the Emergency Department guided by the use of the Manchester Acute Coronary Syndromes (MACS) clinical decision rule, which combines clinical features with levels of two cardiac biomarkers.
Follow Up Length: 6 month(s); Study Entry : Single Randomisation only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Successful early discharge, defined as a decision to discharge from the ED within 4 hours of arrival; Timepoint(s): Assessed once (can be assessed from 30 days after randomisation) (Primary clinical outcome).
Secondary outcome measures
1. Acceptability of trial processes to clinicians and patients; Timepoint(s): Within 30 days of randomisation (feasibility outcome)
2. Attrition (including both failure to complete the trial protocol and loss to follow up); Timepoint(s): Assessed once, on study completion (feasibility outcome)
3. Completeness of data collection; Timepoint(s): Assessed once, on study completion (feasibility outcome)
4. Direct healthcare costs; Timepoint(s): 30 days, 3 months, 6 months
5. Health status (EQ-5D); Timepoint(s): 30 days, 3 months, 6 months
6. Length of initial hospital stay; Timepoint(s): Assessed once, on study completion (clinical outcome)
7. Major adverse cardiac events (death, coronary revascularisation, acute myocardial infarction); Timepoint(s): 30 days, 3 months, 6 months
8. Patient satisfaction; Timepoint(s): 30 days and 6 months
9. Reasons for lack of compliance with the trial protocol; Timepoint(s): Within 30 days of randomisation (feasibility outcome)
10. The number of eligible patients; Timepoint(s): Assessed once, upon study completion (feasibility outcome)
11. The proportion of eligible patients randomised; Timepoint(s): Assessed once, on study completion (feasibility outcome)
Overall trial start date
01/08/2013
Overall trial end date
01/02/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Consenting patients, over 18 years of age, presenting to the ED with pain, discomfort or pressure in the chest, epigastrium, neck, jaw, or upper limb without an apparent non-cardiac source (compatible with the American Heart Association case definitions), which the treating physician believes warrants investigation for a possible acute coronary syndrome.
Target Gender: Male & Female; Upper Age Limit 150 years ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100
Participant exclusion criteria
1. Peak symptoms occurred more than 24 hours prior to presentation
2. Another medical condition necessitating hospital admission
3. Definite ST elevation myocardial infarction needing immediate revasularisation
4. No capacity to provide informed consent
5. Inability to communicate in English language if translation services are unavailable
6. Prisoners
Recruitment start date
01/08/2013
Recruitment end date
01/02/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom
Trial participating centre
Salford Royal Hospital
M6 8HD
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 patient experiences results in: https://www.ncbi.nlm.nih.gov/pubmed/28500089
2017 feasibility results in: https://www.ncbi.nlm.nih.gov/pubmed/28500087