Condition category
Circulatory System
Date applied
09/01/2017
Date assigned
12/01/2017
Last edited
12/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Acute coronary syndrome (ACS) refers to a group of conditions due to decreased blood flow in the coronary arteries such that part of the heart muscle is unable to function properly or dies. It encompasses a range of sudden heart conditions, including heart attack and unstable angina attack (sudden chest pain). ACS mainly happens due to narrowing of the blood vessels which supply the heart due to a build-up of plaque (a fatty, sticky substance) on the walls of arteries. The GRACE risk score tool is a special tool which can be used by healthcare professionals (such as doctors) to calculate the risks of further heart attack or death after acute coronary syndrome (type of unstable angina attack or heart attack), by looking at medical information that is routinely collected during hospital stays. The aim of this study is to find out whether there is a difference in patient’s health status following an unstable angina attack or a heart attack if treated according to usual care or if treated using the GRACE risk score tool.

Who can participate?
Adults who have been admitted to hospital with a suspected acute coronary syndrome.

What does the study involve?
Participating hospitals are randomly allocated to one of two groups. Hospitals in the first group use the GRACE risk score tool within routine clinical assessment and management procedures. This involves individual participants who agree to take part having their GRACE risk score calculated and used to help decide their treatment. Hosptials in the second group continue to follow their current practice. In both groups, participants complete a general health assessment and a short questionnaire at the start of the study and then again 12 months later to assess their health status. Participants’ long-term progress relating to their heart condition is also assessed by reviewing electronic medical records.

What are the possible benefits and risks of participating?
There are no guaranteed benefits of participating, however the information gained from this study could help improve the treatment of people with ACS in the future. There are no notable risks involved with participating.

Where is the study run from?
Thirteen NHS hospitals in England (UK)

When is the study starting and how long is it expected to run for?
May 2015 to June 2021

Who is funding the study?
British Heart Foundation (UK)

Who is the main contact?
Dr Catherine Reynolds
C.Reynolds@leeds.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Catherine Reynolds

ORCID ID

Contact details

Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 113 343 0254
C.Reynolds@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32356

Study information

Scientific title

Effectiveness of the GRACE risk score on the management and outcome of patients hospitalised with non-ST elevation acute coronary syndrome

Acronym

UKGRIS

Study hypothesis

Study aim:
The aim of this study is to evaluate the effectiveness of the systematic clinical application of the GRACE risk score.

Hypothesis:
Compared with current standard care, the implementation of the GRACE risk score tool by healthcare professionals for patients hospitalised with 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.

Ethics approval

NRES Committee North East – Newcastle & North Tyneside 1, 06/11/2014, ref: 14/NE/1180

Study design

Randomised; Interventional; Design type: Process of Care, Management of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Cardiovascular disease, Primary sub-specialty: Heart Failure; UKCRC code/ Disease: Cardiovascular/ Other forms of heart disease

Intervention

Sites are randomised centrally using minimisation including a random element at the CTRU to either the intervention (use of the GRACE risk score) or to current standard care at their site on a 1:1 basis stratified by hospital ACS Volume and primary PCI capability. Sites are randomised prior to opening to recruitment. Sites are excluded from participating in the study if they currently use the GRACE risk score for guiding treatment in this group of participants. Participants are then registered onto the study following a site opening to recruitment and the participant consenting to take part in the study.

Intervention arm: The trial will aim to embed the GRACE risk score tool within routine clinical assessment and management procedures at each of the hospitals randomised to the intervention. Each consenting participant will have their GRACE risk score and corresponding risk of six month mortality estimated by the appointed local research staff / healthcare professional as soon as possible after admission (ideally within twelve hours). Each participant will be classified as either ‘low’ (score:<109), ‘intermediate’ (score: 109 to 140) or ‘high’ (score: >140) risk estimate of six month mortality and this will be clearly recorded on the Risk Scores CRF with a list of abbreviated guideline recommendations for the management of NSTEACS. The trial will collect recommendations followed and reasons for not following recommendations.

Control arm: Participants will be registered into the study and the site will continue with their current practice. CTRU staff will be in regular contacts with sites during the recruitment phase to ensure sites do not change their practices to incorporate the GRACE risk score in their treatment of this group of participants.

All participants will consent to participate in this study following their admission to hospital. Following consent their baseline information will be collected and, dependent on the arm of the trial, their GRACE risk score will be calculated and their treatment recommendations recorded or normal practice will be followed. The recommended timelines for this happening is within 12 hours of the participant being admitted to hospital. Following on from this, a member of the research team will work through a frailty score with the participant and then the participant will complete a short questionnaire.

On discharge from hospital (or death) further data will be collected as to what treatment and medication the participant received during their admission. 12 months after the patient was registered into the study, the patient will be posted a further short questionnaire to complete and send back to the CTRU. The study team will also be applying for follow up data for the participants via electronic health records.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

1. The proportion of care processes (Class 1 guideline-indicated therapies) received across all participants in each hospital as assessed using care processes reported from time of onset of chest pain until discharge from hospital (or death) as recorded on the end of hospital stay CRF.
2. Composite endpoint of cardiovascular death, non-fatal myocardial infarction, new onset heart failure (with hospitalisation) and cardiovascular readmissions at 12 months assessed through electronic health record review at 12 months

Secondary outcome measures

1. Health-related quality of life is measured using the EQ-5D-5L questionnaire at baseline and 12 months
2. Unscheduled revascularisations within 12 months of initial presentation are assessed through electronic health record review at 12 months
3. Length of hospital stay within 12 months of initial presentation is assessed through electronic health record review at 12 months
4. Individual components of the composite endpoints of cardiovascular death, non-fatal myocardial infarction, new onset heart failure (with hospitalisation) and cardiovascular readmission at 12 months assessed through electronic health record review at 12 months

Overall trial start date

11/05/2015

Overall trial end date

30/06/2021

Reason abandoned

Eligibility

Participant inclusion criteria

Research sites inclusion criteria:
1. Acute hospital participating in MINAP
2. Willing to implement the GRACE risk score tool

Patient inclusion criteria:
1. Age greater than or equal to 18 (no upper age limit)
2. Symptoms consistent with acute cardiac ischaemia for >10mins within 24 hours of presentation to hospital
3. One of the following and/or at least two of the High Risk Features:
3.1. ECG changes:
3.1.1. Transient ST-segment elevation of 0.5mm in 2 or more contiguous leads;
3.1.2. ST-segment depression of 0.5mm in 2 or more contiguous leads;
3.1.3. New T wave inversion of 1 mm in 2 or more contiguous leads;
3.1.4. New Q waves [1/3 height of R wave or >0.04 seconds];
3.1.5. New R wave > S wave in lead V1; or,
3.1.6. New left bundle branch block
3.2. Elevated cardiac biomarkers:
3.2.1. Troponin T or I above the upper reference limit (URL);
3.2.2. CK-MB 2x URL; or,
3.2.3. If there is no CK-MB available, then total CK greater than the local URL
3.3. Documented coronary artery disease:
3.3.1. History of MI or angina;
3.3.2. Congestive cardiac failure due to ischaemia;
3.3.3. Resuscitated sudden cardiac death;
3.3.4. Prior or new positive stress test with or without imaging;
3.3.5. Prior or new, cardiac catheterisation, percutaneous coronary artery intervention or coronary artery bypass graft surgery documenting coronary artery disease
3.4. At least 2 of the following High Risk features:
3.4.1. Haemodynamic compromise (SBP <90 mmHg and HR >100 bpm)
3.4.2. Left ventricular systolic dysfunction (LVEF <0.40);
3.4.3. Presence of known diabetes mellitus
3.4.4. Documentation of chronic kidney disease (estimated GFR <60mls/min/m2)
4. Willing and able to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 9000; UK Sample Size: 3000

Participant exclusion criteria

Research sites exclusion criteria:
GRACE risk tool already implemented.

Patient exclusion criteria:
1. Patients presenting at hospital due to an acute ST-segment elevation myocardial infarction (STEMI)
2. Patients presenting at hospital with an ACS accompanied with, or precipitate by significant co-morbidity e.g. motor vehicle accident, trauma, severe gastrointestinal bleeding
3. Peri-operative or peri-procedural MI
4. Patients already recruited into the study

Recruitment start date

23/01/2017

Recruitment end date

31/12/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Trial participating centre

Royal Lancaster Infirmary
Ashton Road
Lancaster
LA1 4RP
United Kingdom

Trial participating centre

Furness General Hospital
Dalton Lane
Barrow-in-Furness
LA14 4LF
United Kingdom

Trial participating centre

Royal Chesterfield Hospital
Top Road Calow
Chesterfield
S44 5BL
United Kingdom

Trial participating centre

Leighton Hospital
Middlewich Road
Crewe
CW1 4QJ
United Kingdom

Trial participating centre

York Hospital
Wiggington Road
York
YO31 8HE
United Kingdom

Trial participating centre

Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

Conquest Hospital
The Ridge
St Leonards On Sea
TN37 7RD
United Kingdom

Trial participating centre

Royal Sussex County Hospital
Sussex Cancer Centre Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Torbay District General Hospital
Heart and Lung Unit Lowes Bridge
Torquay
TQ2 7AA
United Kingdom

Trial participating centre

West Middlesex University Hospital
Chelsea & Westminster Hospital NHS Foundation Trust Twickenham Road
Isleworth
TW7 6AF
United Kingdom

Trial participating centre

Blackpool Victoria Hospital
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom

Trial participating centre

East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom

Sponsor information

Organisation

University of Leeds

Sponsor details

Faculty of Medicine and Health
Room 10.110
Level 10
Worsley Building
Clarendon way
Leeds
LS2 9NL
United Kingdom
+44 113 3437587
governance-ethics@leeds.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes