Acute coronary syndrome (ACS) Circulatory System
Conditions
Interventions
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 bas
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
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 years (no upper age limit) 2. Symptoms consistent with acute cardiac ischaemia for >10 min 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 0.5 mm in 2 or more contiguous leads; 3.1.2. ST-segment depression of 0.5 mm 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 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 <60 ml/min/m2) 4. Willing and able to provide written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 04/06/2021: 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 and 24 months Previous primary outcome measure: 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/06/2021: 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 and 24 months of initial presentation is assessed through electronic health record review at 12 and 24 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 and 24 months assessed through electronic health record review at 12 and 24 months Previous 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactRachael Gilberts
Outcome results
None listed