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Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes

Primary Purpose

Acute Coronary Syndromes, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Educational intervention programme
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Coronary Syndromes focused on measuring non-ST elevation acute coronary syndrome, educational intervention, evidence based practice, guidelines

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Aintree
  • Monklands Hospital
  • Antrim Hospital
  • Barnet General Hospital
  • Barnsley District General Hospital
  • Basildon Hospital
  • North Hampshire Hospital
  • Mater Infirmorum Hospital
  • Royal Victoria Hospital
  • Birmingham Heartlands Hospital
  • Bridlington And District Hospital
  • The Royal Sussex County Hospital
  • Cumberland Infirmary
  • Leighton Hospital
  • Darent Valley Hospital
  • Eastbourne District General Hospital
  • Western Infirmary
  • Withybush General Hospital
  • Altnagelvin Area Hospital
  • Luton and Dunstable Hospital
  • Macclesfield District General Hospital
  • Northampton General Hospital
  • Royal Alexandra Hospital
  • Pontefract General Infirmary
  • Whiston Hospital
  • Oldchurch Hospital
  • Rotherham District General Hospital
  • Hope Hospital
  • University Hospital Of North Tees
  • University Hospital Of North Staffordshire
  • Wordsley Hospital
  • Taunton and Somerset Hospital
  • Torbay Hospital
  • Pinderfields General Hospital
  • West Cumberland Hospital
  • Royal Albert Edward Infirmary
  • Wrexham Maelor Hospital

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
July 15, 2008
Last Updated
July 15, 2008
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Sanofi, Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00716352
Brief Title
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

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Sanofi, Bristol-Myers Squibb

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes, Coronary Artery Disease
Keywords
non-ST elevation acute coronary syndrome, educational intervention, evidence based practice, guidelines

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
1340 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Educational intervention programme
Primary Outcome Measure Information:
Title
Adherence to the educational programme measured by the frequency of use of the evidence based treatments: Aspirin, Heparin, Clopidogrel, Beta blockers, Statins.
Secondary Outcome Measure Information:
Title
Comparison of investigations and tests
Title
Use of other treatments
Title
Counselling for lifestyle changes
Title
Referral to smoking cessation clinics
Title
Cardiac rehabilitation
Title
Compliance to treatment at 6 months
Title
Comparison of clinical events at 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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: Ischaemic changes on the admission ECG (including patients with bundle branch block) Elevated Troponin or cardiac enzymes on admission 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: Patients with persistent ST elevation >1mm in two or more contiguous leads on the ECG. Patients treated with thrombolytic therapy, or for whom thrombolytic therapy was considered on admission.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Flather
Organizational Affiliation
Royal Brompton & Harefield NHS Trust, Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aintree
City
Aintree
Country
United Kingdom
Facility Name
Monklands Hospital
City
Airdrie
Country
United Kingdom
Facility Name
Antrim Hospital
City
Antrim
Country
United Kingdom
Facility Name
Barnet General Hospital
City
Barnet
Country
United Kingdom
Facility Name
Barnsley District General Hospital
City
BArnsley
Country
United Kingdom
Facility Name
Basildon Hospital
City
Basildon
Country
United Kingdom
Facility Name
North Hampshire Hospital
City
Basingstoke
Country
United Kingdom
Facility Name
Mater Infirmorum Hospital
City
Belfast
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Belfast
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Bridlington And District Hospital
City
Bridlington
Country
United Kingdom
Facility Name
The Royal Sussex County Hospital
City
Brighton
Country
United Kingdom
Facility Name
Cumberland Infirmary
City
Carlisle
Country
United Kingdom
Facility Name
Leighton Hospital
City
Crewe
Country
United Kingdom
Facility Name
Darent Valley Hospital
City
Dartford
Country
United Kingdom
Facility Name
Eastbourne District General Hospital
City
Eastbourne
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
Country
United Kingdom
Facility Name
Withybush General Hospital
City
Haverfordwest
Country
United Kingdom
Facility Name
Altnagelvin Area Hospital
City
Londonderry
Country
United Kingdom
Facility Name
Luton and Dunstable Hospital
City
Luton
Country
United Kingdom
Facility Name
Macclesfield District General Hospital
City
Macclesfield
Country
United Kingdom
Facility Name
Northampton General Hospital
City
Northampton
Country
United Kingdom
Facility Name
Royal Alexandra Hospital
City
Paisley
Country
United Kingdom
Facility Name
Pontefract General Infirmary
City
Pontefract
Country
United Kingdom
Facility Name
Whiston Hospital
City
Prescot
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
Country
United Kingdom
Facility Name
Rotherham District General Hospital
City
Rotherham
Country
United Kingdom
Facility Name
Hope Hospital
City
Salford
Country
United Kingdom
Facility Name
University Hospital Of North Tees
City
Stockton-on-Tees
Country
United Kingdom
Facility Name
University Hospital Of North Staffordshire
City
Stoke-on-Trent
Country
United Kingdom
Facility Name
Wordsley Hospital
City
Stourbridge
Country
United Kingdom
Facility Name
Taunton and Somerset Hospital
City
Taunton
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay
Country
United Kingdom
Facility Name
Pinderfields General Hospital
City
Wakefield
Country
United Kingdom
Facility Name
West Cumberland Hospital
City
Whitehaven
Country
United Kingdom
Facility Name
Royal Albert Edward Infirmary
City
Wigan
Country
United Kingdom
Facility Name
Wrexham Maelor Hospital
City
Wrexham
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.cteu.org
Description
Central co-ordinating centre website

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Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes

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