The Australian Cooperative National Registry of Acute Coronary care, Guideline Adherence and Clinical Events
- Conditions
- Acute Coronary SyndromesCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12614000887673
- Lead Sponsor
- Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 8000
All patients must have symptoms of an ACS plus one of the following: ECG changes, elevated enzymes, previous history of CAD, new documentation of CAD or two features of high risk ACS.
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 high risk features for CAD.
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;
-CK-MB 2x upper limit of the hospitals normal range or if there is no CK-MB 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
The qualifying acute coronary syndrome must not be precipitated or accompanied by a co-morbidity such as trauma or major bleeding and patients already hospitalised for any reason when the ACS develops are not eligible for enrolment in CONCORDANCE.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary purpose of the registry is to provide data to health care providers and hospitals to characterise existing and evolving practice patterns, delivery of care, and resource utilization in the management of ACS across Australia. For example the following process measures are provided; <br>Door to balloon time for patients with ST elevation MI receiving PCI; Door to needle time for patients with STEMI receiving fibrinolysis and proportion of high risk non-ST elevation ACS patients receiving in hospital angiography.<br>[These data are provided to clinicians as on-line real-time performance measure reports (key performance indicators -KPIs) benchmarked against national aggregate data.<br><br>]
- Secondary Outcome Measures
Name Time Method To document and inform the appropriate use of medications in the Australian ACS population, including higher risk subsets not well represented in clinical trials. For example these data are provided to clinicians as on-line real-time performance measure reports (key performance indicators -KPIs) benchmarked against national aggregate data. Proportion of STEMI and high risk non-ST elevation ACS patients receiving in hospital clopidogrel; proportion of high risk non-ST elevation ACS receiving glycoprotein GPIIb/IIIa antagonist therapy; proportion of ACS patients discharged on beta-blocker; proportion of ACS patients discharged on ACE-inhibitor or Angiotensin Receptor Blocker; proportion of ACS patients discharged on aspirin and proportion of ACS patients discharged on statin therapy.<br>[These data are provided to clinicians as on-line real-time performance measure reports (key performance indicators -KPIs) benchmarked against national aggregate data.<br><br>]