Acute Coronary SyndromeEQUIP-ACSNCT00716430
European Quality Improvement Programme for Acute Coronary Syndromes
A study testing Quality Improvement Programme in people with Acute Coronary Syndrome, run by Royal Brompton & Harefield NHS Foundation Trust at 37 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Quality Improvement Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 37 sitesin 5 countries
- Study dates
- Aug 2007to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Evidence of persistent ST elevation on the ECG
- Use of early reperfusion therapy
- Patients >80 years
- Patients transferred from another hospital
Trial locations and contacts
37 sites in 5 countries.
37 sites in 5 countries
Poland10 sites, 10 recruiting
- Recruiting
Szpital w Ciechanowie
Ciechanów
Bogdan Zbyszynski
- Recruiting
Szpital Zachodni
Grodzisk Mazowiecki
Marek Stopinski
- Recruiting
Szpital w Grojcu
Grójec
Zbigniew Binio
- Recruiting
Swietofrzyskie Centrum Chorob Serca
Kielce
Marianna Janion
- Recruiting
Szpital w Plocku
Płock
Maciej Rynkiewicz
- Recruiting
Radomski Szpital Specjalistyczny
Radom
Piotr Achremczyk
- Recruiting
Szpital Specjalistyczny SPZOZ w Radom
Radom
Bozena Wrzosek
- Recruiting
Szpital w Siedlcach
Siedlce
Piotr Kolodziej
- Recruiting
SP CSK- Medical University of Warsaw
Warsaw
Grzegorz Opolski
- Recruiting
Szpital we Wloclawku
Włocławek
Jerzy Kopaczewski
France8 sites, 8 recruiting
- Recruiting
Centre Hospitalier de la region d'Annecy
Annecy
Loic Belle
- Recruiting
Centre Hospitalier de Chambery
Chambéry
Christian Chaussard
- Recruiting
Cardiology dept. B, CHU Hopital G. Montpied
Clermont-Ferrand
Bernard Citron
- Recruiting
CHU de Grenoble
Grenoble
Gerald Vanzetto
- Recruiting
Centre Hospitalier de Riom Guy Thomas
Riom
Laurence Flork
- Recruiting
Hopitaux Drome Nord de Romans-sur-Isere
Romans-sur-Isère
Christian Chaussard
- Recruiting
Centre Hospitalier d'Ussel
Ussel
Alain Berenfeld
- Recruiting
Centre Hospitalier Pierre Bazin
Voiron
Hubert Mann
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitario Germans Trias
Badalona
Antonio Curos Abadal
- Recruiting
Hospital del Mar
Barcelona
Lluis Recasens Gracia
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona
Jose Barrabes
- Recruiting
Hospital Josep Trueta
Girona
Joan Sala
- Recruiting
Hospital Universitario Joan XXIII
Tarragona
Ramon de Castro
- Recruiting
Hospital de Terrassa
Terrassa-Barcelona
Antonio Sanchez Hidalgo
- Recruiting
Hospital de Tortosa Virgen de la Cinta
Tortosa
David Bierge Valero
United Kingdom7 sites, 7 recruiting
- Recruiting
Antrim Area Hospital
Antrim
Thomas Trouton
- Recruiting
Barnet General Hospital
Barnet
Ameet Bakhai
- Recruiting
Basildon Hospital
Essex
Rajesh Aggarwal
- Recruiting
Warwick Hospital
Warwick
Najmi Qureshi
- Recruiting
Royal Albert Edward Infirmary
Wigan
Sanjay Arya
- Recruiting
Yeovil District Hospital
Yeovil
George Chung
- Recruiting
York District Hospital
York
Maurice Pye
Italy5 sites, 5 recruiting
- Recruiting
Ospedale M. Bufalini
Cesena
Flavio Tartagni
- Recruiting
Ospedale Morgagni-Pierantoni
Forlì
Filippo Ottani
- Recruiting
Ospedale di Livorno
Livorno
Michele Galli
- Recruiting
Ospedale Civile di Mirano
Mirano
Luca Favero
- Recruiting
Ospedale Generale Provinciale di Macerata
Province of Macerata
Gian Luigi Morgagni
About this study
Official title: Improving the Management of Non-ST Elevation Acute Coronary Syndrome: Systematic Evaluation of a Quality Improvement Programme
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Quality Improvement Programme
- Keywords
- acute coronary syndromes, quality improvement
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement ProgrammeBehavioural
Quality Improvement training programme
| Study group | Role | What they receive |
|---|---|---|
| QI | Active comparator | Quality Improvement Centres Receives: Behavioral: Quality Improvement Programme |
| Non-QI | No intervention | No Quality Improvement Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 months
Secondary outcomes (3)
Clinical outcomes at discharge including death and myocardial infarction
Measured: 10 months
Estimated costs of care for patients
Measured: 10 months
Estimated costs and economic evaluation of potential cost-effectiveness of QI programme
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startAug 2007
- Primary completionDec 2008 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716430
- Sponsor's protocol ID
- EQUIP-ACS 1
- Acronym
- EQUIP-ACS
- Status last verified
- Jul 2008
- First submitted
- 11 Jul 2008
- Last updated
- 16 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21982663Flather 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.
PubMed 20074348
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Management of Non-ST Elevation Acute Coronary Syndrome: Systematic Evaluation of a Quality Improvement Programme
- ClinicalTrials.gov ID
- NCT00716430
- Acronym / sponsor ID
- EQUIP-ACS / EQUIP-ACS 1
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndromes, quality improvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Uppsala University, GlaxoSmithKline
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QI | Active comparator | Behavioral: Quality Improvement ProgrammeQuality Improvement Centres |
| Non-QI | No intervention | –No Quality Improvement Programme |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Evidence of persistent ST elevation on the ECG
- Use of early reperfusion therapy
- Patients >80 years
- Patients transferred from another hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality Improvement ProgrammeQuality Improvement training programme | Behavioural | QI |
Primary outcome
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
3 secondary outcomes
Clinical outcomes at discharge including death and myocardial infarction
Time frame: 10 months
Estimated costs of care for patients
Time frame: 10 months
Estimated costs and economic evaluation of potential cost-effectiveness of QI programme
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2008.
- Derived from this study: PubMed 21982663Flather 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.
- Derived from this study: PubMed 20074348Flather 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
37 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Improvement Programme in people with Acute Coronary Syndrome, run by Royal Brompton & Harefield NHS Foundation Trust at 37 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Poland, France, Spain, United Kingdom, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcus D Flather (0044 (0) 207 351 8827, m.flather@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00716430, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2008.