European Quality Improvement Programme for Acute Coronary Syndromes

Acute Coronary Syndrome Clinical Trial

— EQUIP-ACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00716430
• Other study ID #: EQUIP-ACS 1
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2008
• Last updated: July 15, 2008
• Start date: August 2007
• Est. completion date: February 2009

Study information

• Verified date: July 2008
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: Marcus D Flather
• Phone: 0044 (0) 207 351 8827
• Email: m.flather[@]rbht.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeFrance: Comite d'Ethique des Centres d'Investigation CliniqueSpain: Comité Ético de Investigación ClínicaItaly: National Ethics CommitteePoland: Komisja Bioetyczna
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Behavioral:
• Quality Improvement Programme
Quality Improvement training programme

Locations

Country	Name	City	State
France	Centre Hospitalier de la region d'Annecy	Annecy
France	Centre Hospitalier de Chambery	Chambery
France	Cardiology dept. B, CHU Hopital G. Montpied	Clermont Ferrand
France	CHU de Grenoble	Grenoble
France	Centre Hospitalier de Riom Guy Thomas	Riom
France	Hopitaux Drome Nord de Romans-sur-Isere	Romans-sur-Isere
France	Centre Hospitalier d'Ussel	Ussel
France	Centre Hospitalier Pierre Bazin	Voiron
Italy	Ospedale M. Bufalini	Cesena
Italy	Ospedale Morgagni-Pierantoni	Forli
Italy	Ospedale di Livorno	Livorno
Italy	Ospedale Generale Provinciale di Macerata	Macerata
Italy	Ospedale Civile di Mirano	Mirano
Poland	Szpital w Ciechanowie	Ciechanow
Poland	Szpital Zachodni	Grodzisk Mazowiecki
Poland	Szpital w Grojcu	Grojec
Poland	Swietofrzyskie Centrum Chorob Serca	Kielce
Poland	Szpital w Plocku	Plock
Poland	Radomski Szpital Specjalistyczny	Radom
Poland	Szpital Specjalistyczny SPZOZ w Radom	Radom
Poland	Szpital w Siedlcach	Siedlce
Poland	SP CSK- Medical University of Warsaw	Warsaw
Poland	Szpital we Wloclawku	Wloclawek
Spain	Hospital Universitario Germans Trias	Badalona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Josep Trueta	Girona
Spain	Hospital Universitario Joan XXIII	Tarragona
Spain	Hospital de Terrassa	Terrassa-Barcelona
Spain	Hospital de Tortosa Virgen de la Cinta	Tortosa
United Kingdom	Antrim Area Hospital	Antrim
United Kingdom	Barnet General Hospital	Barnet
United Kingdom	Basildon Hospital	Essex
United Kingdom	Warwick Hospital	Warwick
United Kingdom	Royal Albert Edward Infirmary	Wigan
United Kingdom	Yeovil District Hospital	Yeovil
United Kingdom	York District Hospital	York

Sponsors (3)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	GlaxoSmithKline, Uppsala University

Countries where clinical trial is conducted

France,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical outcomes at discharge including death and myocardial infarction		10 months	No
Secondary	Estimated costs of care for patients		10 months	No
Secondary	Estimated costs and economic evaluation of potential cost-effectiveness of QI programme		10 months	No