UKGRIS

Background
Acute coronary syndrome (ACS) which includes ST-elevation myocardial infarction (STEMI), non ST-elevation myocardial infarction (NSTEMI) and unstable angina (UA) comprises the leading cause of emergency hospitalisation in Europe, a leading cause of death and disability and have major impacts on health economies. Non ST-elevation ACS (NSTEACS) describes a heterogeneous spectrum of patients, including NSTEMI and UA whose prognosis is determined by both baseline clinical risk and the use of evidence-based therapies. NSTEACS represent over half of the cases of ACS of which NSTEMI account for around 50,000 National Health Service hospitalisations per year. The prevalence of NSTEACS increases with age and so the number of people expected to experience NSTEACS is increasing as the population ages. Patients hospitalised with NSTEMI have a high risk (>3%) of in-hospital mortality, but also of cardiogenic shock (>4%), requirement for transfusion (>4%) and recurrent myocardial infarction (>2%) during the hospital stay. However, estimates vary according to patients’ baseline clinical risks and therefore there are a range of treatment options for NSTEACS. For example, whether a patient proceeds to an immediate, urgent or delayed coronary angiography and revascularisation and which antithrombotic regimen is chosen depends on individual risk characteristics. Evidence from randomised controlled trials (RCTs) as well as guideline recommendations from the European Society of Cardiology (ESC) and the National Institute for Health and Care Excellence (NICE) support the use of different strategies according to risk status because allocation of a treatment strategy significantly reduces subsequent cardiovascular events. In place of generic treatment of all patients, stratified care has the potential to achieve cost-effective patient-centred treatment as well as improved outcomes.

Aim
The aim of the study is to evaluate the effectiveness of the systematic clinical application of the GRACE risk score. The study will test the hypothesis that, compared with current standard care, the implementation of the GRACE risk score tool by healthcare professionals for patients hospitalised with non-ST elevation acute coronary syndrome (NSTEACS) increases the use of Class 1 guideline-indicated therapies for the management of NSTEACS and reduces the composite endpoints of cardiovascular death, non-fatal myocardial infarction, new onset heart failure (with admission) and cardiovascular readmission at twelve months.

Primary objectives
To determine whether:

1. Implementing the GRACE risk score increases the use of Class 1 guideline-indicated therapies for the management of NSTEACS, within the guideline recommended time, compared with current standard care.
2. Implementing the GRACE risk score reduces the composite endpoints of cardiovascular death, non-fatal myocardial infarction, new onset heart failure with hospitalisation and cardiovascular readmission at twelve months, compared with current standard care.

Secondary objectives
To determine whether implementing the GRACE risk score has an impact on:

1. Health-related quality of life at twelve months
2. Unscheduled revascularisations within twelve months of initial presentation
3. Length of hospital stay within twelve months of initial presentation
4. Individual components of the composite endpoints of cardiovascular death, non-fatal myocardial infarction, new onset heart failure (with hospitalisation) and cardiovascular readmission at twelve months

Design
UKGRIS is a multi-national, open label, cluster-randomised, pragmatic, registry-based trial involving 3000 patients recruited in sites throughout England. Information gathered from participants during their hospital stay and at 12 months will be linked to electronic health records and national audits to obtain further information related to the study’s primary and secondary objectives.

Sample Size
3000 participants will be recruited over 30 months.

Study Status: Recruiting

Chief Investigator
Dr Chris Gale, University of Leeds

Trial Contacts
Trial and Data Management:
Ms Catherine Reynolds
Tel: 0113 343 0254

Project Delivery Lead:
Dr Catherine Fernandez
Tel: 0113 343 4895

Email
Ctru-grace@leeds.ac.uk

Study Update
The study opened to recruitment in February 2017. As at January 2018, more than 900 participants have been recruited into the study and 28 sites have opened to recruitment.

In March 2018 the first participants recruited into the study will have completed their first year and we will be sending out their 12 month questionnaire.

For participants
Have you helped us by taking part in the UKGRIS study for investigation into the effectiveness of the GRACE risk score? This British Heart Foundation funded study started recruiting in February 2017 with a planned end of recruitment in December 2019. We would like to remind you that when you signed the consent form for the study you gave us permission to access health information about you up to five years after the study time period. This simply means that if you were to die or be admitted to hospital during this time we are informed of the cause of your death or admission. We obtain this information from the Office of National Statistics and via NHS Digital.

What information will we collect about you?
We send your NHS number, Surname, Forename, Date of Birth and Postcode to NHS Digital and in return they will inform us if you have died or been admitted to hospital, and if this is the case what the cause of your death or admission to hospital was.

How will we use the information about you?
We will link this information to the information we already hold about you from the study. As before your name and address will be removed from any medical data so you cannot be identified.

What if I do not want my information to be collected?
Please get in touch with the research team (details below) to opt-out and we will not send your NHS number to NHS Digital.

Who has organized this project?
The UKGRIS study is undertaken by the Leeds Institute of Clinical Trials Research, which is a group of researchers working within the University of Leeds. The chief investigator for the study is Professor Chris Gale.

Who controls my data?
The Data Controller is the University of Leeds

Who is my data shared with?
Information about you will be seen by researchers at the University of Leeds and the Clinical Trials Research Unit but will not be shared with other organizations unless it has been made completely anonymous.

Who can I contact if I want to know more or to opt-out?
Please email us on Ctru-grace@leeds.ac.uk or ring 0113 343 0254

If preferred you can write to us:

Clinical Trials Research Unit
Leeds Institute of Clinical Trials Research
University of Leeds
Leeds
LS2 9JT

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