The Australian Grace Risk score Intervention study (AGRIS): a hospital level cluster randomised clinical trial with blinded endpoint evaluation which aims to enhance evidence based decision making and outcome delivery of Australian Acute Coronary Syndrome (ACS) care by evaluating a GRACE Risk score based decision support tool versus standard care

Not Applicable

Recruiting

• Conditions: Acute Coronary Syndromes; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12614000550606
• Lead Sponsor: Sydney Local Health District - Concord Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

Hospital-level

* Admit at least 15 ACS patients a month.
* The presence of an onsite 24/7 emergency service.
* ED, Cardiology/medicine services willing to implement the GRACE Risk tool and treatment recommendation plan into their care process.

Patient Level Inclusion Criteria:
Patients are eligible if they present to hospital with symptoms felt to be consistent with acute cardiac ischaemia for >10mins within 24 hours of presentation to hospital plus one of the following: ECG changes; elevated enzymes; documentation of CAD or documentation of 2 or more features of high risk ACS:

ECG changes:
-transient ST segment elevation of 0.5mm in two or more contiguous leads;
-ST segment depression of 0.5mm in two or more contiguous leads
-new T wave inversion of 1 mm in two or more contiguous leads
-new Q waves (1/3 height of R wave or >0.04 seconds)
-new R wave > S wave in lead V1 (posterior MI)
-new left bundle branch block

Increase in cardiac enzymes:
-increase in troponin T above the upper limit of normal
- increase in troponin I above the upper limit of normal;
CKMB
-2x upper limit of the hospitals normal range or if there is no CKMB available, then total CK greater than the upper limit of normal.

Documentation of Coronary Artery Disease
- history of MI, angina, congestive cardiac failure due to ischaemia or resuscitated sudden cardiac death
-history of or new positive stress test with or without imaging;
- prior or new, cardiac catheterisation documenting coronary artery disease
- prior or new percutaneous coronary artery intervention or coronary artery bypass graft surgery

At least 2 of the following High Risk features:
- haemodynamic compromise (BP<90 and HR >100)
-left ventricular systolic dysfunction (LVEF<0.40);
-presence of known diabetes
-documentation of chronic kidney disease (estimated GFR <60mls/min

Exclusion Criteria

Hospitals with an existing implemented risk stratification support system for the management of ACS patients will be excluded.

Patients presenting to hospital with an ACS accompanied with, or precipitated by significant co-morbidity e.g. motor vehicle accident, trauma, severe gastrointestinal bleeding, peri-operative or peri-procedural MI will be excluded and patients already hospitalised for any reason when the ACS develops are
not eligible for enrolment in the registry.

Patients already recruited into the study can only be re-enrolled after the 12 month follow up period has been reached.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of risk stratification using the GRACE Risk tool and treatment recommendation plan for ACS patients on the in-hospital use of evidence-based investigations and therapies and secondary prevention assessed at the time of discharge.<br>Data is extracted from the medical records and entered into an electronic Case Report Form. <br>The primary (hospital performance measure) endpoint will be the composite endpoint of adherence to performance measures (receipt of angiography; receipt of 4/5 recommended therapies and referral to cardiac rehabilitation) by the time of discharge among those patients discharged alive.[At discharge from hospital admission.]

Secondary Outcome Measures

Name	Time	Method
To determine the incremental net clinical benefit and cost-effectiveness of risk stratification using the GRACE Risk tool and treatment recommendation plan on care within the routine clinical environment.<br>Data is extracted from the medical records and entered into an electronic Case Report Form. <br>Cost effectiveness will be measured by data linkage to the Medicare Benefits Scheme and Pharmaceutical Benefits Scheme and Quality of Life (EQ5D) as completed by the patient.<br> <br>[This secondary objective will be measured on discharge from hospital. ];To determine the incremental net clinical benefit of risk stratification using the GRACE Risk tool and treatment recommendation plan on the reduction of cardiovascular death, myocardial infarction, new or worsening heart failure, and readmissions for cardiovascular or significant bleeding at 12 months.<br>Data is obtained via patient follow up 12 months post admission to hospital. <br>[This will be measured at 12 months post discharge from hospital.]