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Trial registered on ANZCTR


Registration number
ACTRN12609000491268
Ethics application status
Approved
Date submitted
5/06/2009
Date registered
19/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Pathways for Acute Coronary Syndromes in China - phase 2: implementation and evaluation
Scientific title
In patients with acute coronary syndromes admitted to urban hospitals in China, are clinical pathways effective for improving the quality of care.
Universal Trial Number (UTN)
Trial acronym
CPACS-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes 4866 0
Condition category
Condition code
Cardiovascular 237218 237218 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clinical pathways in this study are standardized algorithms for the treatment of acute coronary syndromes that aim to optimize and streamline patient care. They are established according to American Heart Association (AHA) and American College of Cardiology (ACC) guidelines to promote the use of evidence-based treatments for high risk patients and ultimately, improve clinical outcomes. The clinical pathways are designed to accompany the patient’s medical record and available in printed copy. In this study after baseline data collection, the printed clinical pathways as a reminder of guideline adherence will be added in front of patient’s medical record in relevant departments in the participating hospitals. The clinical pathways will be used for at least 24 month in participating hospitals. Its impact will be evaluated periodically (every 6 months) by comparing a series of key performance indicators, e.g. average door-to needle time and average door-to-balloon time for patients with ST elevated myocardial infarction.
Intervention code [1] 236649 0
Behaviour
Comparator / control treatment
1. Randomized comparison: hospitals will be selected to implement the clinical pathways “early” and to implement “12 month later”. Approximately one-half of the 75 participating hospitals will be allocated (at random, stratified by hospital size and level) to commence the study in the first year of the full program (Group A), while the remaining one-half (Group B) will commence during the second year. This staggered commencement will be necessary from a logistic viewpoint, but will also provide the opportunity to make a randomized evaluation of the intervention program on the key performance indicators (12 month data for Group A vs. baseline data for Group B).
2. Non-randomized comparison: a “before-after” comparison in key performance indicators among all 75 hospitals will be conducted from up to 3750 patients (50 patients from each of the 75 hospitals) at each 6-month interval with baseline and the previous 6-month time periods. After 24 months, summary data will be available for over 15000 patients to examine overall trends in key performance indicators.
Control group
Active

Outcomes
Primary outcome [1] 238030 0
Proportion of ST elevated myocardial infarction patients arriving at hospital within 12 hours of symptom onset who receive thrombolysis or primary percutaneous coronary intervention
Timepoint [1] 238030 0
Before and after the intervention
Primary outcome [2] 238031 0
Proportion of patients with final diagnosis (unstable angina pectoris or myocardial infarction) consistent with biomarker findings (blood test results for Creatine Phosphokinase and Triponin)
Timepoint [2] 238031 0
Before and after the intervention
Primary outcome [3] 238032 0
Door-to-needle time for ST elevated myocardial infarction patients undergoing thrombolysis
Timepoint [3] 238032 0
Before and after the intervention
Secondary outcome [1] 242183 0
Proportion of high-risk patients undergoing coronary angiography
Timepoint [1] 242183 0
Before and after the intervention
Secondary outcome [2] 242184 0
Proportion of low-risk patients (no ongoing symptoms, persistently normal Electrocardiography, persistently normal serum Creatine Phosphokinase and Triponin value) undergoing functional testing (exercise test and stress echocardiography)
Timepoint [2] 242184 0
Before and after the intervention
Secondary outcome [3] 242185 0
Proportion of patients discharged on appropriate medical therapy for secondary prevention (antiplatelets, beta-blockers, Angiotensin-Converting Enzymeinhibitors (ACE) inhibitors and statins being prescripted when patients are discharged )
Timepoint [3] 242185 0
Before and after the intervention
Secondary outcome [4] 242186 0
Mean length-of-stay in hospital
Timepoint [4] 242186 0
Before and after the intervention
Secondary outcome [5] 242187 0
Door-to-balloon time for ST elevated myocardial infarction patients undergoing primary Percutaneous Coronary Intervention (PCI) (where primary PCI is offered)
Timepoint [5] 242187 0
Before and after the intervention

Eligibility
Key inclusion criteria
Hospitals routinely admitting patients with acute coronary syndromes are included in the study; patients over 17 years old and being hospitalised due to acute coronary syndromes are included in the study.
Minimum age
17 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hospitals currently admitting fewer than 100 patients with suspected acute coronary syndromes per year will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation was performed at hospital level. Allocation of hospitals to early or later commencing group was concealed by central randomisation by computer. Allocation is not concealed at individual patient level.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1809 0
China
State/province [1] 1809 0

Funding & Sponsors
Funding source category [1] 237118 0
Commercial sector/Industry
Name [1] 237118 0
Sanofi-Aventis (China)
Address [1] 237118 0
Floor 32, No.1266
Nanjing West Road
Shanghai, 200040
Country [1] 237118 0
China
Primary sponsor type
Commercial sector/Industry
Name
Sanofi-Aventis (China)
Address
Floor 32, No.1266
Nanjing West Road
Shanghai, 200040
Country
China
Secondary sponsor category [1] 4569 0
None
Name [1] 4569 0
Address [1] 4569 0
Country [1] 4569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239163 0
The university of sydney
Ethics committee address [1] 239163 0
Research Office
Level 6, Jane Foss Russell Building G02
The University of Sydney NSW 2006
Ethics committee country [1] 239163 0
Australia
Date submitted for ethics approval [1] 239163 0
Approval date [1] 239163 0
26/09/2007
Ethics approval number [1] 239163 0
09-2007/10276

Summary
Brief summary
Coronary heart disease is now a leading cause of disease in China. The strategies for managing acute coronary syndromes (ACS) are well-recognised, however, anecdotal reports suggest that many patients do not receive recommended therapies. This study aims to develop, implement and evaluate quality improvement initiatives (using clinical pathways) throughout selected hospitals in China, to increase the use of recommended treatments and reduce the use of expensive and unnecessary investigations and treatment. Over the long term, this could lead to substantial reductions in the rates of disability and death due to ACS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29656 0
Address 29656 0
Country 29656 0
Phone 29656 0
Fax 29656 0
Email 29656 0
Contact person for public queries
Name 12903 0
Ye Rong
Address 12903 0
Level 10, King George V Building
Royal Prince Alfred Hospital
Missenden Road
Camperdown
Sydney NSW 2050
Country 12903 0
Australia
Phone 12903 0
+61 2 8507 2523
Fax 12903 0
Email 12903 0
rye@george.org.au
Contact person for scientific queries
Name 3831 0
Fiona Turnbull
Address 3831 0
Level 10, King George V Building
Royal Prince Alfred Hospital
Missenden Road
Camperdown
Sydney NSW 2050
Country 3831 0
Australia
Phone 3831 0
+61 2 9993 4563
Fax 3831 0
Email 3831 0
FTurnbull@george.org.au

No information has been provided regarding IPD availability
Summary results
No Results