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

Primary Purpose

Acute Coronary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Quality Improvement Programme
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Coronary Syndrome focused on measuring acute coronary syndromes, quality improvement

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de la region d'AnnecyRecruiting
  • Centre Hospitalier de ChamberyRecruiting
  • Cardiology dept. B, CHU Hopital G. MontpiedRecruiting
  • CHU de GrenobleRecruiting
  • Centre Hospitalier de Riom Guy ThomasRecruiting
  • Hopitaux Drome Nord de Romans-sur-IsereRecruiting
  • Centre Hospitalier d'UsselRecruiting
  • Centre Hospitalier Pierre BazinRecruiting
  • Ospedale M. BufaliniRecruiting
  • Ospedale Morgagni-PierantoniRecruiting
  • Ospedale di LivornoRecruiting
  • Ospedale Generale Provinciale di MacerataRecruiting
  • Ospedale Civile di MiranoRecruiting
  • Szpital w CiechanowieRecruiting
  • Szpital ZachodniRecruiting
  • Szpital w GrojcuRecruiting
  • Swietofrzyskie Centrum Chorob SercaRecruiting
  • Szpital w PlockuRecruiting
  • Radomski Szpital SpecjalistycznyRecruiting
  • Szpital Specjalistyczny SPZOZ w RadomRecruiting
  • Szpital w SiedlcachRecruiting
  • SP CSK- Medical University of WarsawRecruiting
  • Szpital we WloclawkuRecruiting
  • Hospital Universitario Germans TriasRecruiting
  • Hospital del MarRecruiting
  • Hospital Universitario Vall d'HebronRecruiting
  • Hospital Josep TruetaRecruiting
  • Hospital Universitario Joan XXIIIRecruiting
  • Hospital de TerrassaRecruiting
  • Hospital de Tortosa Virgen de la CintaRecruiting
  • Antrim Area HospitalRecruiting
  • Barnet General HospitalRecruiting
  • Basildon HospitalRecruiting
  • Warwick HospitalRecruiting
  • Royal Albert Edward InfirmaryRecruiting
  • Yeovil District HospitalRecruiting
  • York District HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

QI

Non-QI

Arm Description

Quality Improvement Centres

No Quality Improvement Programme

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical outcomes at discharge including death and myocardial infarction
Estimated costs of care for patients
Estimated costs and economic evaluation of potential cost-effectiveness of QI programme

Full Information

First Posted
July 11, 2008
Last Updated
July 15, 2008
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Uppsala University, GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00716430
Brief Title
European Quality Improvement Programme for Acute Coronary Syndromes
Acronym
EQUIP-ACS
Official Title
Improving the Management of Non-ST Elevation Acute Coronary Syndrome: Systematic Evaluation of a Quality Improvement Programme
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Uppsala University, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
acute coronary syndromes, quality improvement

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QI
Arm Type
Active Comparator
Arm Description
Quality Improvement Centres
Arm Title
Non-QI
Arm Type
No Intervention
Arm Description
No Quality Improvement Programme
Intervention Type
Behavioral
Intervention Name(s)
Quality Improvement Programme
Intervention Description
Quality Improvement training programme
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Clinical outcomes at discharge including death and myocardial infarction
Time Frame
10 months
Title
Estimated costs of care for patients
Time Frame
10 months
Title
Estimated costs and economic evaluation of potential cost-effectiveness of QI programme
Time Frame
10 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus D Flather
Phone
0044 (0) 207 351 8827
Email
m.flather@rbht.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Daphne Babalis
Phone
0044 (0) 207 351 8889
Email
d.babalis@rbht.nhs.uk
Facility Information:
Facility Name
Centre Hospitalier de la region d'Annecy
City
Annecy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loic Belle
Facility Name
Centre Hospitalier de Chambery
City
Chambery
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Chaussard
Facility Name
Cardiology dept. B, CHU Hopital G. Montpied
City
Clermont Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard Citron
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald Vanzetto
Facility Name
Centre Hospitalier de Riom Guy Thomas
City
Riom
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Flork
Facility Name
Hopitaux Drome Nord de Romans-sur-Isere
City
Romans-sur-Isere
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Chaussard
Facility Name
Centre Hospitalier d'Ussel
City
Ussel
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Berenfeld
Facility Name
Centre Hospitalier Pierre Bazin
City
Voiron
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hubert Mann
Facility Name
Ospedale M. Bufalini
City
Cesena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavio Tartagni
Facility Name
Ospedale Morgagni-Pierantoni
City
Forli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filippo Ottani
Facility Name
Ospedale di Livorno
City
Livorno
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Galli
Facility Name
Ospedale Generale Provinciale di Macerata
City
Macerata
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gian Luigi Morgagni
Facility Name
Ospedale Civile di Mirano
City
Mirano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Favero
Facility Name
Szpital w Ciechanowie
City
Ciechanow
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan Zbyszynski
Facility Name
Szpital Zachodni
City
Grodzisk Mazowiecki
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Stopinski
Facility Name
Szpital w Grojcu
City
Grojec
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zbigniew Binio
Facility Name
Swietofrzyskie Centrum Chorob Serca
City
Kielce
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianna Janion
Facility Name
Szpital w Plocku
City
Plock
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maciej Rynkiewicz
Facility Name
Radomski Szpital Specjalistyczny
City
Radom
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Achremczyk
Facility Name
Szpital Specjalistyczny SPZOZ w Radom
City
Radom
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bozena Wrzosek
Facility Name
Szpital w Siedlcach
City
Siedlce
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Kolodziej
Facility Name
SP CSK- Medical University of Warsaw
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grzegorz Opolski
Facility Name
Szpital we Wloclawku
City
Wloclawek
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerzy Kopaczewski
Facility Name
Hospital Universitario Germans Trias
City
Badalona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Curos Abadal
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lluis Recasens Gracia
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Barrabes
Facility Name
Hospital Josep Trueta
City
Girona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Sala
Facility Name
Hospital Universitario Joan XXIII
City
Tarragona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramon de Castro
Facility Name
Hospital de Terrassa
City
Terrassa-Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Sanchez Hidalgo
Facility Name
Hospital de Tortosa Virgen de la Cinta
City
Tortosa
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Bierge Valero
Facility Name
Antrim Area Hospital
City
Antrim
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Trouton
Facility Name
Barnet General Hospital
City
Barnet
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ameet Bakhai
Facility Name
Basildon Hospital
City
Essex
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajesh Aggarwal
Facility Name
Warwick Hospital
City
Warwick
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Najmi Qureshi
Facility Name
Royal Albert Edward Infirmary
City
Wigan
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Arya
Facility Name
Yeovil District Hospital
City
Yeovil
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Chung
Facility Name
York District Hospital
City
York
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurice Pye

12. IPD Sharing Statement

Citations:
PubMed Identifier
21982663
Citation
Flather MD, Babalis D, Booth J, Bardaji A, Machecourt J, Opolski G, Ottani F, Bueno H, Banya W, Brady AR, Bojestig M, Lindahl B. Cluster-randomized trial to evaluate the effects of a quality improvement program on management of non-ST-elevation acute coronary syndromes: The European Quality Improvement Programme for Acute Coronary Syndromes (EQUIP-ACS). Am Heart J. 2011 Oct;162(4):700-707.e1. doi: 10.1016/j.ahj.2011.07.027.
Results Reference
derived
PubMed Identifier
20074348
Citation
Flather MD, Booth J, Babalis D, Bueno H, Steg PG, Opolski G, Ottani F, Machecourt J, Bardaji A, Bojestig M, Brady AR, Lindahl B. Improving the management of non-ST elevation acute coronary syndromes: systematic evaluation of a quality improvement programme European QUality Improvement Programme for Acute Coronary Syndrome: the EQUIP-ACS project protocol and design. Trials. 2010 Jan 14;11:5. doi: 10.1186/1745-6215-11-5.
Results Reference
derived

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European Quality Improvement Programme for Acute Coronary Syndromes

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