Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes

Sponsor
Royal Brompton & Harefield NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT00716352
Collaborator
Sanofi (Industry), Bristol-Myers Squibb (Industry)
1,340
37
20
36.2
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational intervention programme
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1340 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Primary Purpose:
Health Services Research
Official Title:
Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes
Study Start Date :
Mar 1, 2004
Actual Study Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Adherence to the educational programme measured by the frequency of use of the evidence based treatments: Aspirin, Heparin, Clopidogrel, Beta blockers, Statins. []

Secondary Outcome Measures

  1. Comparison of investigations and tests []

  2. Use of other treatments []

  3. Counselling for lifestyle changes []

  4. Referral to smoking cessation clinics []

  5. Cardiac rehabilitation []

  6. Compliance to treatment at 6 months []

  7. Comparison of clinical events at 6 months []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Aintree Aintree United Kingdom
2 Monklands Hospital Airdrie United Kingdom
3 Antrim Hospital Antrim United Kingdom
4 Barnet General Hospital Barnet United Kingdom
5 Barnsley District General Hospital BArnsley United Kingdom
6 Basildon Hospital Basildon United Kingdom
7 North Hampshire Hospital Basingstoke United Kingdom
8 Mater Infirmorum Hospital Belfast United Kingdom
9 Royal Victoria Hospital Belfast United Kingdom
10 Birmingham Heartlands Hospital Birmingham United Kingdom
11 Bridlington And District Hospital Bridlington United Kingdom
12 The Royal Sussex County Hospital Brighton United Kingdom
13 Cumberland Infirmary Carlisle United Kingdom
14 Leighton Hospital Crewe United Kingdom
15 Darent Valley Hospital Dartford United Kingdom
16 Eastbourne District General Hospital Eastbourne United Kingdom
17 Western Infirmary Glasgow United Kingdom
18 Withybush General Hospital Haverfordwest United Kingdom
19 Altnagelvin Area Hospital Londonderry United Kingdom
20 Luton and Dunstable Hospital Luton United Kingdom
21 Macclesfield District General Hospital Macclesfield United Kingdom
22 Northampton General Hospital Northampton United Kingdom
23 Royal Alexandra Hospital Paisley United Kingdom
24 Pontefract General Infirmary Pontefract United Kingdom
25 Whiston Hospital Prescot United Kingdom
26 Oldchurch Hospital Romford United Kingdom
27 Rotherham District General Hospital Rotherham United Kingdom
28 Hope Hospital Salford United Kingdom
29 University Hospital Of North Tees Stockton-on-Tees United Kingdom
30 University Hospital Of North Staffordshire Stoke-on-Trent United Kingdom
31 Wordsley Hospital Stourbridge United Kingdom
32 Taunton and Somerset Hospital Taunton United Kingdom
33 Torbay Hospital Torquay United Kingdom
34 Pinderfields General Hospital Wakefield United Kingdom
35 West Cumberland Hospital Whitehaven United Kingdom
36 Royal Albert Edward Infirmary Wigan United Kingdom
37 Wrexham Maelor Hospital Wrexham United Kingdom

Sponsors and Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust
  • Sanofi
  • Bristol-Myers Squibb

Investigators

  • Principal Investigator: Marcus Flather, Royal Brompton & Harefield NHS Trust, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00716352
Other Study ID Numbers:
  • MREC/03/10/48
First Posted:
Jul 16, 2008
Last Update Posted:
Jul 16, 2008
Last Verified:
Jul 1, 2008

Study Results

No Results Posted as of Jul 16, 2008