Clinical trial NCT00716430: European Quality Improvement Programme for Acute Coronary Syndromes
Official title: Improving the Management of Non-ST Elevation Acute Coronary Syndrome: Systematic Evaluation of a Quality Improvement Programme
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: acute coronary syndromes
quality improvement
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: GlaxoSmithKline
First posted: 2008-07-16
Enrollment: 3500
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: 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
timeFrame: 10 months
Secondary outcomes:
measure: Clinical outcomes at discharge including death and myocardial infarction
timeFrame: 10 months
measure: Estimated costs of care for patients
timeFrame: 10 months
measure: Estimated costs and economic evaluation of potential cost-effectiveness of QI programme
timeFrame: 10 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: Centre Hospitalier de la region d'Annecy
city: Chambery
country: France
facility: Centre Hospitalier de Chambery
city: Clermont Ferrand
country: France
facility: Cardiology dept. B, CHU Hopital G. Montpied
city: Grenoble
country: France
facility: CHU de Grenoble
city: Riom
country: France
facility: Centre Hospitalier de Riom Guy Thomas
city: Romans-sur-Isere
country: France
facility: Hopitaux Drome Nord de Romans-sur-Isere
city: Ussel
country: France
facility: Centre Hospitalier d'Ussel
city: Voiron
country: France
facility: Centre Hospitalier Pierre Bazin
city: Cesena
country: Italy
facility: Ospedale M. Bufalini
city: Forli
country: Italy
facility: Ospedale Morgagni-Pierantoni
city: Livorno
country: Italy
facility: Ospedale di Livorno
city: Macerata
country: Italy
facility: Ospedale Generale Provinciale di Macerata
city: Mirano
country: Italy
facility: Ospedale Civile di Mirano
city: Ciechanow
country: Poland
facility: Szpital w Ciechanowie
city: Grodzisk Mazowiecki
country: Poland
facility: Szpital Zachodni
city: Grojec
country: Poland
facility: Szpital w Grojcu
city: Kielce
country: Poland
facility: Swietofrzyskie Centrum Chorob Serca
city: Plock
country: Poland
facility: Szpital w Plocku
city: Radom
country: Poland
facility: Radomski Szpital Specjalistyczny
city: Radom
country: Poland
facility: Szpital Specjalistyczny SPZOZ w Radom
city: Siedlce
country: Poland
facility: Szpital w Siedlcach
city: Warsaw
country: Poland
facility: SP CSK- Medical University of Warsaw
city: Wloclawek
country: Poland
facility: Szpital we Wloclawku
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Girona
country: Spain
facility: Hospital Josep Trueta
city: Tarragona
country: Spain
facility: Hospital Universitario Joan XXIII
city: Terrassa-Barcelona
country: Spain
facility: Hospital de Terrassa
city: Tortosa
country: Spain
facility: Hospital de Tortosa Virgen de la Cinta
city: Antrim
country: United Kingdom
facility: Antrim Area Hospital
city: Barnet
country: United Kingdom
facility: Barnet General Hospital
city: Essex
country: United Kingdom
facility: Basildon Hospital
city: Warwick
country: United Kingdom
facility: Warwick Hospital
city: Wigan
country: United Kingdom
facility: Royal Albert Edward Infirmary
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
city: York
country: United Kingdom
facility: York District Hospital
Study officials:
References:
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.
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.