European Quality Improvement Programme for Acute Coronary Syndromes (EQUIP-ACS)

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

Improving the Management of Non-ST Elevation Acute Coronary Syndrome: Systematic Evaluation of a Quality Improvement Programme

The main hypothesis to be tested is that the use of a quality improvement programme will lead to measurable improvements in the management of care and use of evidence based treatments for patients presenting to hospital with non-ST elevation acute coronary syndromes.

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
3500

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Annecy, France
        • Recruiting
        • Centre Hospitalier de la région d'Annecy
        • Principal Investigator:
          • Loic Belle
      • Chambery, France
        • Recruiting
        • Centre Hospitalier de Chambery
        • Principal Investigator:
          • Christian Chaussard
      • Clermont Ferrand, France
        • Recruiting
        • Cardiology dept. B, CHU Hopital G. Montpied
        • Principal Investigator:
          • Bernard Citron
      • Grenoble, France
        • Recruiting
        • CHU de GRENOBLE
        • Principal Investigator:
          • Gerald Vanzetto
      • Riom, France
        • Recruiting
        • Centre Hospitalier de Riom Guy Thomas
        • Principal Investigator:
          • Laurence Flork
      • Romans-sur-Isere, France
        • Recruiting
        • Hopitaux Drome Nord de Romans-sur-Isere
        • Principal Investigator:
          • Christian Chaussard
      • Ussel, France
        • Recruiting
        • Centre Hospitalier d'Ussel
        • Principal Investigator:
          • Alain Berenfeld
      • Voiron, France
        • Recruiting
        • Centre Hospitalier Pierre Bazin
        • Principal Investigator:
          • Hubert Mann
  • Italy
      • Cesena, Italy
        • Recruiting
        • Ospedale M. Bufalini
        • Principal Investigator:
          • Flavio Tartagni
      • Forli, Italy
        • Recruiting
        • Ospedale Morgagni-Pierantoni
        • Principal Investigator:
          • Filippo Ottani
      • Livorno, Italy
        • Recruiting
        • Ospedale di Livorno
        • Principal Investigator:
          • Michele Galli
      • Macerata, Italy
        • Recruiting
        • Ospedale Generale Provinciale di Macerata
        • Principal Investigator:
          • Gian Luigi Morgagni
      • Mirano, Italy
        • Recruiting
        • Ospedale Civile Di Mirano
        • Principal Investigator:
          • Luca Favero
  • Poland
      • Ciechanow, Poland
        • Recruiting
        • Szpital w Ciechanowie
        • Principal Investigator:
          • Bogdan Zbyszynski
      • Grodzisk Mazowiecki, Poland
        • Recruiting
        • Szpital Zachodni
        • Principal Investigator:
          • Marek Stopinski
      • Grojec, Poland
        • Recruiting
        • Szpital w Grojcu
        • Principal Investigator:
          • Zbigniew Binio
      • Kielce, Poland
        • Recruiting
        • Swietofrzyskie Centrum Chorob Serca
        • Principal Investigator:
          • Marianna Janion
      • Plock, Poland
        • Recruiting
        • Szpital w Plocku
        • Principal Investigator:
          • Maciej Rynkiewicz
      • Radom, Poland
        • Recruiting
        • Radomski Szpital Specjalistyczny
        • Principal Investigator:
          • Piotr Achremczyk
      • Radom, Poland
        • Recruiting
        • Szpital Specjalistyczny SPZOZ w Radom
        • Principal Investigator:
          • Bozena Wrzosek
      • Siedlce, Poland
        • Recruiting
        • Szpital w Siedlcach
        • Principal Investigator:
          • Piotr Kolodziej
      • Warsaw, Poland
        • Recruiting
        • SP CSK- Medical University of Warsaw
        • Principal Investigator:
          • Grzegorz Opolski
      • Wloclawek, Poland
        • Recruiting
        • Szpital we Wloclawku
        • Principal Investigator:
          • Jerzy Kopaczewski
  • Spain
      • Badalona, Spain
        • Recruiting
        • Hospital Universitario Germans Trias
        • Principal Investigator:
          • Antonio Curos Abadal
      • Barcelona, Spain
        • Recruiting
        • Hospital Del Mar
        • Principal Investigator:
          • Lluis Recasens Gracia
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Principal Investigator:
          • Jose Barrabes
      • Girona, Spain
        • Recruiting
        • Hospital Josep Trueta
        • Principal Investigator:
          • Joan Sala
      • Tarragona, Spain
        • Recruiting
        • Hospital Universitario Joan XXIII
        • Principal Investigator:
          • Ramon de Castro
      • Terrassa-Barcelona, Spain
        • Recruiting
        • Hospital de Terrassa
        • Principal Investigator:
          • Antonio Sanchez Hidalgo
      • Tortosa, Spain
        • Recruiting
        • Hospital de Tortosa Virgen de la Cinta
        • Principal Investigator:
          • David Bierge Valero
  • United Kingdom
      • Antrim, United Kingdom
        • Recruiting
        • Antrim Area Hospital
        • Principal Investigator:
          • Thomas Trouton
      • Barnet, United Kingdom
        • Recruiting
        • Barnet General Hospital
        • Principal Investigator:
          • Ameet Bakhai
      • Essex, United Kingdom
        • Recruiting
        • Basildon Hospital
        • Principal Investigator:
          • Rajesh Aggarwal
      • Warwick, United Kingdom
        • Recruiting
        • Warwick Hospital
        • Principal Investigator:
          • Najmi Qureshi
      • Wigan, United Kingdom
        • Recruiting
        • Royal Albert Edward Infirmary
        • Principal Investigator:
          • Sanjay Arya
      • Yeovil, United Kingdom
        • Recruiting
        • Yeovil District Hospital
        • Principal Investigator:
          • George Chung
      • York, United Kingdom
        • Recruiting
        • York District Hospital
        • Principal Investigator:
          • Maurice Pye

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

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with a good clinical history of ACS and at least one of the following:

  • New or transient ST or T wave changes on the ECG consistent with acute myocardial ischaemia
  • Elevation of troponin or other cardiac markers to levels indicative of myocardial necrosis according to local laboratory values

Exclusion Criteria:

  • Evidence of persistent ST elevation on the ECG
  • Use of early reperfusion therapy
  • Patients >80 years
  • Patients transferred from another hospital

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
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: QI
Quality Improvement Centres
Behavioral: Quality Improvement Programme
Quality Improvement training programme
No Intervention: Non-QI
No Quality Improvement Programme

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
Time Frame
Composite of 7 outcome measures to assess aggregate potential for improvement in care using the QI programme:1:risk stratification within 24 hrs, 2:early coronary angiography, 3:anticoagulation, 4:beta-blockers, 5:statins, 6:ACE-inhibitors, 7:Clopidogrel
Time Frame: 10 months
10 months

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
Time Frame
Clinical outcomes at discharge including death and myocardial infarction
Time Frame: 10 months
10 months
Estimated costs of care for patients
Time Frame: 10 months
10 months
Estimated costs and economic evaluation of potential cost-effectiveness of QI programme
Time Frame: 10 months
10 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.
GlaxoSmithKline
Uppsala University

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.

General Publications

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.
August 1, 2007

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (Anticipated)

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.
February 1, 2009

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 11, 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.
  • EQUIP-ACS 1

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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