Clinical trial NCT00716352: Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes
Official title: Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndromes
Coronary Artery Disease
Keywords: non-ST elevation acute coronary syndrome
educational intervention
evidence based practice
guidelines
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Bristol-Myers Squibb
First posted: 2008-07-16
Enrollment: 1340
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a multi-centre UK study designed to evaluate if an educational intervention programme delivered to health care professionals can improve the use of evidence based treatments in the management of patients admitted to hospital with non-ST elevation Acute Coronary Syndrome. A total of 38 centres participated, half received the educational intervention. Patients were followed to hospital discharge. Patients were followed up at 6 months. Longer term follow up through the Office Of National Statistics will be performed.

Detailed description: This is a multi-centre UK study designed to evaluate if an educational intervention programme delivered to health care professionals can improve the use of evidence based treatments in the management of patients admitted to hospital with non-ST elevation Acute Coronary Syndrome. A total of 38 centres participated. A cluster randomised method was used and half of centres received the educational intervention. Patients were followed to hospital discharge. Patients were followed up at 6 months and longer term follow up for mortality will be performed through the national databases.

Eligibility criteria: Inclusion Criteria:All patients admitted to the hospital (either through casualty or directly to the wards), with a good clinical history of an acute coronary syndrome with one or more of the following:

1. Ischaemic changes on the admission ECG (including patients with bundle branch block)
2. Elevated Troponin or cardiac enzymes on admission
3. Normal ECGs but with evidence of pre-existing coronary artery disease i.e., evidence of a prior history of MI, coronary revascularisation, coronary angiography demonstrating the presence of significant coronary stenosis or a stress test demonstrating ischaemia (treadmill, echo or nuclear scan)

Written informed consent

Exclusion Criteria:

1. Patients with persistent ST elevation \>1mm in two or more contiguous leads on the ECG.
2. Patients treated with thrombolytic therapy, or for whom thrombolytic therapy was considered on admission.

Primary outcomes:
measure: Adherence to the educational programme measured by the frequency of use of the evidence based treatments: Aspirin, Heparin, Clopidogrel, Beta blockers, Statins.
Secondary outcomes:
measure: Comparison of investigations and tests
measure: Use of other treatments
measure: Counselling for lifestyle changes
measure: Referral to smoking cessation clinics
measure: Cardiac rehabilitation
measure: Compliance to treatment at 6 months
measure: Comparison of clinical events at 6 months
Other outcomes:
Locations:
city: Aintree
country: United Kingdom
facility: University Hospital Aintree
city: Airdrie
country: United Kingdom
facility: Monklands Hospital
city: Antrim
country: United Kingdom
facility: Antrim Hospital
city: Barnet
country: United Kingdom
facility: Barnet General Hospital
city: BArnsley
country: United Kingdom
facility: Barnsley District General Hospital
city: Basildon
country: United Kingdom
facility: Basildon Hospital
city: Basingstoke
country: United Kingdom
facility: North Hampshire Hospital
city: Belfast
country: United Kingdom
facility: Mater Infirmorum Hospital
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Bridlington
country: United Kingdom
facility: Bridlington And District Hospital
city: Brighton
country: United Kingdom
facility: The Royal Sussex County Hospital
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary
city: Crewe
country: United Kingdom
facility: Leighton Hospital
city: Dartford
country: United Kingdom
facility: Darent Valley Hospital
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
city: Glasgow
country: United Kingdom
facility: Western Infirmary
city: Haverfordwest
country: United Kingdom
facility: Withybush General Hospital
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital
city: Luton
country: United Kingdom
facility: Luton and Dunstable Hospital
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
city: Paisley
country: United Kingdom
facility: Royal Alexandra Hospital
city: Pontefract
country: United Kingdom
facility: Pontefract General Infirmary
city: Prescot
country: United Kingdom
facility: Whiston Hospital
city: Romford
country: United Kingdom
facility: Oldchurch Hospital
city: Rotherham
country: United Kingdom
facility: Rotherham District General Hospital
city: Salford
country: United Kingdom
facility: Hope Hospital
city: Stockton-on-Tees
country: United Kingdom
facility: University Hospital Of North Tees
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospital Of North Staffordshire
city: Stourbridge
country: United Kingdom
facility: Wordsley Hospital
city: Taunton
country: United Kingdom
facility: Taunton and Somerset Hospital
city: Torquay
country: United Kingdom
facility: Torbay Hospital
city: Wakefield
country: United Kingdom
facility: Pinderfields General Hospital
city: Whitehaven
country: United Kingdom
facility: West Cumberland Hospital
city: Wigan
country: United Kingdom
facility: Royal Albert Edward Infirmary
city: Wrexham
country: United Kingdom
facility: Wrexham Maelor Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Trust, Imperial College London
name: Marcus Flather
role: PRINCIPAL_INVESTIGATOR
References: