NCT00716430

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
5 countries

37 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

July 16, 2008

Status Verified

July 1, 2008

Enrollment Period

1.3 years

First QC Date

July 11, 2008

Last Update Submit

July 15, 2008

Conditions

Keywords

acute coronary syndromesquality improvement

Outcome Measures

Primary Outcomes (1)

  • 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

    10 months

Secondary Outcomes (3)

  • Clinical outcomes at discharge including death and myocardial infarction

    10 months

  • Estimated costs of care for patients

    10 months

  • Estimated costs and economic evaluation of potential cost-effectiveness of QI programme

    10 months

Study Arms (2)

QI

ACTIVE COMPARATOR

Quality Improvement Centres

Behavioral: Quality Improvement Programme

Non-QI

NO INTERVENTION

No Quality Improvement Programme

Interventions

Quality Improvement training programme

QI

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Centre Hospitalier de la region d'Annecy

Annecy, France

RECRUITING

Centre Hospitalier de Chambery

Chambéry, France

RECRUITING

Cardiology dept. B, CHU Hopital G. Montpied

Clermont-Ferrand, France

RECRUITING

CHU de Grenoble

Grenoble, France

RECRUITING

Centre Hospitalier de Riom Guy Thomas

Riom, France

RECRUITING

Hopitaux Drome Nord de Romans-sur-Isere

Romans-sur-Isère, France

RECRUITING

Centre Hospitalier d'Ussel

Ussel, France

RECRUITING

Centre Hospitalier Pierre Bazin

Voiron, France

RECRUITING

Ospedale M. Bufalini

Cesena, Italy

RECRUITING

Ospedale Morgagni-Pierantoni

Forlì, Italy

RECRUITING

Ospedale di Livorno

Livorno, Italy

RECRUITING

Ospedale Generale Provinciale di Macerata

Macerata, Italy

RECRUITING

Ospedale Civile di Mirano

Mirano, Italy

RECRUITING

Szpital w Ciechanowie

Ciechanów, Poland

RECRUITING

Szpital Zachodni

Grodzisk Mazowiecki, Poland

RECRUITING

Szpital w Grojcu

Grójec, Poland

RECRUITING

Swietofrzyskie Centrum Chorob Serca

Kielce, Poland

RECRUITING

Szpital w Plocku

Płock, Poland

RECRUITING

Radomski Szpital Specjalistyczny

Radom, Poland

RECRUITING

Szpital Specjalistyczny SPZOZ w Radom

Radom, Poland

RECRUITING

Szpital w Siedlcach

Siedlce, Poland

RECRUITING

SP CSK- Medical University of Warsaw

Warsaw, Poland

RECRUITING

Szpital we Wloclawku

Włocławek, Poland

RECRUITING

Hospital Universitario Germans Trias

Badalona, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, Spain

RECRUITING

Hospital Josep Trueta

Girona, Spain

RECRUITING

Hospital Universitario Joan XXIII

Tarragona, Spain

RECRUITING

Hospital de Terrassa

Terrassa-Barcelona, Spain

RECRUITING

Hospital de Tortosa Virgen de la Cinta

Tortosa, Spain

RECRUITING

Antrim Area Hospital

Antrim, United Kingdom

RECRUITING

Barnet General Hospital

Barnet, United Kingdom

RECRUITING

Basildon Hospital

Essex, United Kingdom

RECRUITING

Warwick Hospital

Warwick, United Kingdom

RECRUITING

Royal Albert Edward Infirmary

Wigan, United Kingdom

RECRUITING

Yeovil District Hospital

Yeovil, United Kingdom

RECRUITING

York District Hospital

York, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2008

First Posted

July 16, 2008

Study Start

August 1, 2007

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

July 16, 2008

Record last verified: 2008-07

Locations