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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1340

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Royal Brompton & Harefield NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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