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Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Bristol-Myers Squibb
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00716352
First received: July 15, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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 Intervention
Acute Coronary Syndromes
Coronary Artery Disease
Behavioral: Educational intervention programme

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Health Services Research
Official Title: Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes

Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

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

Enrollment: 1340
Study Start Date: March 2004
Study Completion Date: November 2005
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716352

Locations
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, 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00716352     History of Changes
Other Study ID Numbers: MREC/03/10/48
Study First Received: July 15, 2008
Last Updated: July 15, 2008
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
non-ST elevation acute coronary syndrome
educational intervention
evidence based practice
guidelines

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Syndrome
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014