Acute Coronary SyndromesNCT00716352
Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes
A study testing Educational intervention programme in people with Acute Coronary Syndromes and Coronary Artery Disease, run by Royal Brompton & Harefield NHS Foundation Trust at 37 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndromes, Coronary Artery Disease
- What is being tested?
- Educational intervention programme
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,340 participants
- Where
- 37 sitesUnited Kingdom
- Study dates
- Mar 2004to Nov 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United Kingdom37 sites
University Hospital Aintree
Aintree
Monklands Hospital
Airdrie
Antrim Hospital
Antrim
Barnet General Hospital
Barnet
Barnsley District General Hospital
Barnsley
Basildon Hospital
Basildon
North Hampshire Hospital
Basingstoke
Mater Infirmorum Hospital
Belfast
Royal Victoria Hospital
Belfast
Birmingham Heartlands Hospital
Birmingham
Bridlington And District Hospital
Bridlington
The Royal Sussex County Hospital
Brighton
Cumberland Infirmary
Carlisle
Leighton Hospital
Crewe
Darent Valley Hospital
Dartford
Eastbourne District General Hospital
Eastbourne
Western Infirmary
Glasgow
Withybush General Hospital
Haverfordwest
Altnagelvin Area Hospital
Londonderry
Luton and Dunstable Hospital
Luton
Macclesfield District General Hospital
Macclesfield
Northampton General Hospital
Northampton
Royal Alexandra Hospital
Paisley
Pontefract General Infirmary
Pontefract
Whiston Hospital
Prescot
Oldchurch Hospital
Romford
Rotherham District General Hospital
Rotherham
Hope Hospital
Salford
University Hospital Of North Tees
Stockton-on-Tees
University Hospital Of North Staffordshire
Stoke-on-Trent
Wordsley Hospital
Stourbridge
Taunton and Somerset Hospital
Taunton
Torbay Hospital
Torquay
Pinderfields General Hospital
Wakefield
West Cumberland Hospital
Whitehaven
Royal Albert Edward Infirmary
Wigan
Wrexham Maelor Hospital
Wrexham
About this study
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.
Read the 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.
- Conditions
- Acute Coronary Syndromes, Coronary Artery Disease
- Being tested
- Educational intervention programme
- Keywords
- non-ST elevation acute coronary syndrome, educational intervention, evidence based practice, guidelines
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention programmeBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the educational programme measured by the frequency of use of the evidence based treatments: Aspirin, Heparin, Clopidogrel, Beta blockers, Statins.
Secondary outcomes (7)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startMar 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 1,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Bristol-Myers Squibb
- Investigators
- Marcus Flather, Principal investigator, Royal Brompton & Harefield NHS Trust, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716352
- Sponsor's protocol ID
- MREC/03/10/48
- Status last verified
- Jul 2008
- First submitted
- 15 Jul 2008
- Last updated
- 16 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Outcomes and Management of Acute Ischaemic Syndromes
- ClinicalTrials.gov ID
- NCT00716352
- Acronym / sponsor ID
- MREC/03/10/48
- Conditions
- Acute Coronary Syndromes, Coronary Artery Disease
- Keywords
- non-ST elevation acute coronary syndrome, educational intervention, evidence based practice, guidelines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,340 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sanofi, Bristol-Myers Squibb
- Study start
- Mar 2004
- Study completion
- Nov 2005 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational intervention programme | Behavioural | – |
Primary outcome
Adherence to the educational programme measured by the frequency of use of the evidence based treatments: Aspirin, Heparin, Clopidogrel, Beta blockers, Statins.
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2008.
- Central co-ordinating centre websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Flather principal investigator
Royal Brompton & Harefield NHS Trust, Imperial College London
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention programme in people with Acute Coronary Syndromes and Coronary Artery Disease, run by Royal Brompton & Harefield NHS Foundation Trust at 37 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the educational programme measured by the frequency of use of the evidence based treatments: Aspirin, Heparin, Clopidogrel, Beta blockers, Statins.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2008.