Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes

July 15, 2008 updated by: Royal Brompton & Harefield NHS Foundation Trust
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Comparison of investigations and tests
Use of other treatments
Counselling for lifestyle changes
Referral to smoking cessation clinics
Cardiac rehabilitation
Compliance to treatment at 6 months
Comparison of clinical events at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Collaborators

Bristol-Myers Squibb
Sanofi

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

July 15, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

July 16, 2008

Last Update Submitted That Met QC Criteria

July 15, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MREC/03/10/48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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