Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes

Coronary Artery Disease Clinical Trial

Official title:

Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716352
• Other study ID #: MREC/03/10/48
• Status: Completed
• Phase: N/A
• First received: July 15, 2008
• Last updated: July 15, 2008
• Start date: March 2004
• Est. completion date: November 2005

Study information

• Verified date: July 2008
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1340
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Syndrome

Intervention

Behavioral:
• Educational intervention programme

Locations

Country	Name	City	State
United Kingdom	University Hospital Aintree	Aintree
United Kingdom	Monklands Hospital	Airdrie
United Kingdom	Antrim Hospital	Antrim
United Kingdom	Barnet General Hospital	Barnet
United Kingdom	Barnsley District General Hospital	BArnsley
United Kingdom	Basildon Hospital	Basildon
United Kingdom	North Hampshire Hospital	Basingstoke
United Kingdom	Mater Infirmorum Hospital	Belfast
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Bridlington And District Hospital	Bridlington
United Kingdom	The Royal Sussex County Hospital	Brighton
United Kingdom	Cumberland Infirmary	Carlisle
United Kingdom	Leighton Hospital	Crewe
United Kingdom	Darent Valley Hospital	Dartford
United Kingdom	Eastbourne District General Hospital	Eastbourne
United Kingdom	Western Infirmary	Glasgow
United Kingdom	Withybush General Hospital	Haverfordwest
United Kingdom	Altnagelvin Area Hospital	Londonderry
United Kingdom	Luton and Dunstable Hospital	Luton
United Kingdom	Macclesfield District General Hospital	Macclesfield
United Kingdom	Northampton General Hospital	Northampton
United Kingdom	Royal Alexandra Hospital	Paisley
United Kingdom	Pontefract General Infirmary	Pontefract
United Kingdom	Whiston Hospital	Prescot
United Kingdom	Oldchurch Hospital	Romford
United Kingdom	Rotherham District General Hospital	Rotherham
United Kingdom	Hope Hospital	Salford
United Kingdom	University Hospital Of North Tees	Stockton-on-Tees
United Kingdom	University Hospital Of North Staffordshire	Stoke-on-Trent
United Kingdom	Wordsley Hospital	Stourbridge
United Kingdom	Taunton and Somerset Hospital	Taunton
United Kingdom	Torbay Hospital	Torquay
United Kingdom	Pinderfields General Hospital	Wakefield
United Kingdom	West Cumberland Hospital	Whitehaven
United Kingdom	Royal Albert Edward Infirmary	Wigan
United Kingdom	Wrexham Maelor Hospital	Wrexham

Sponsors (3)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	Bristol-Myers Squibb, Sanofi

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the educational programme measured by the frequency of use of the evidence based treatments: Aspirin, Heparin, Clopidogrel, Beta blockers, Statins.
Secondary	Comparison of investigations and tests
Secondary	Use of other treatments
Secondary	Counselling for lifestyle changes
Secondary	Referral to smoking cessation clinics
Secondary	Cardiac rehabilitation
Secondary	Compliance to treatment at 6 months
Secondary	Comparison of clinical events at 6 months