European Quality Improvement Programme for Acute Coronary Syndromes - Full Text View

Sponsors and Collaborators:	Royal Brompton & Harefield NHS Foundation Trust Uppsala Clinical Research GlaxoSmithKline
Information provided by:	Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT00716430

Purpose

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.

Condition	Intervention
Acute Coronary Syndrome	Behavioral: Quality Improvement Programme

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Improving the Management of Non-ST Elevation Acute Coronary Syndrome: Systematic Evaluation of a Quality Improvement Programme

Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

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 [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical outcomes at discharge including death and myocardial infarction [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Estimated costs of care for patients [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Estimated costs and economic evaluation of potential cost-effectiveness of QI programme [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	3500
Study Start Date:	August 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
QI: Active Comparator Quality Improvement Centres	Behavioral: Quality Improvement Programme Quality Improvement training programme
Non-QI: No Intervention No Quality Improvement Programme

Eligibility

Ages Eligible for Study:	up to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716430

Contacts

Contact: Marcus D Flather	0044 (0) 207 351 8827	m.flather@rbht.nhs.uk
Contact: Daphne Babalis	0044 (0) 207 351 8889	d.babalis@rbht.nhs.uk

Locations

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

Sponsors and Collaborators

Royal Brompton & Harefield NHS Foundation Trust

Uppsala Clinical Research

GlaxoSmithKline

More Information

Additional Information:

Project database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Royal Brompton Hospital ( Dr Marcus Flather )
Study ID Numbers:	EQUIP-ACS 1
Study First Received:	July 11, 2008
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00716430 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee; France: Comite d'Ethique des Centres d'Investigation Clinique; Spain: Comité Ético de Investigación Clínica; Italy: National Ethics Committee; Poland: Komisja Bioetyczna

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:

acute coronary syndromes
quality improvement

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Heart Diseases
Pathologic Processes
Disease
Myocardial Ischemia

Syndrome
Acute Coronary Syndrome
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009