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Clinical Pathways for the Management of Acute Coronary Syndromes - Phase 3 (CPACS-3)

This study is not yet open for participant recruitment.
Verified July 2011 by The George Institute for Global Health, China
Sponsor:
Information provided by:
The George Institute for Global Health, China
ClinicalTrials.gov Identifier:
NCT01398228
First received: July 18, 2011
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

The burden of chronic, non-communicable disease, of which cardiovascular disease comprises a significant component, has increased rapidly and substantially in China over recent years. Over the coming decades China is predicted to experience a 69% increase in acute coronary disease(ACS), amounting to nearly 8 million additional events. A recent randomized trial of more than 15,000 patients with acute coronary syndromes, the second phase of Clinical Pathway for acute coronary syndromes in China (CPACS-2) study, showed that a quality improvement initiative could improve aspects of hospital care, including the proportion of patients discharged on appropriate medication. The study also identified a number of barriers to improved care including out of pocket costs and administration systems. However, the study was not able to determine the impact on clinical outcomes or the cost-effectiveness of the intervention. The aim of the third phase of the Clinical Pathway for acute coronary syndromes in China (CPACS-3) study is to determine whether a complex intervention comprising a clinical pathway for ACS management in combination with a number of physician and patient-oriented education tools can improve the quality of care and health outcomes among ACS patient admitted to resource-limited (provincial) hospitals. The effectiveness of the intervention will be evaluated using a cluster randomized trial (stepped wedge design) of ACS patients admitted to 96 hospitals in China. The study will incorporate two additional components (1) a qualitative substudy to identify the barriers and enablers to improved care and (2) a study comparing the cost-effectiveness of the intervention compared to usual care, from the perspective of the health care provider. The study will be conducted in conjunction with the Chinese Ministry of Health and the Chinese Society of Cardiology. The findings from CPACS3 will be able to inform health policy-makers about the extent to which quality improvement initiatives can reduce the risk of death and disability among the millions of ACS patients admitted to hospitals in China each year.


Condition Intervention
Acute Coronary Syndrome
 Behavioral: quality improvement initiatives

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Further study details as provided by The George Institute for Global Health, China:

Primary Outcome Measures:
  • incidence rate of in-hospital major adverse cardiovascular events (MACE) [ Time Frame: during hospitaliztion, an expected average of 10 days ] [ Designated as safety issue: No ]
    In-hospital major adverse cardiovascular events (MACE) comprising all-cause mortality, myocardial infarction or re-infarction and stroke.


Secondary Outcome Measures:
  • door to ECG time [ Time Frame: During Hospitalization, an expected average of 10 days ] [ Designated as safety issue: No ]
  • proportion of patients receiving aspirin/clopidogrel/statin within 24 hours of arrival at hospital [ Time Frame: during hospitaliztion, an expected average of 10 days ] [ Designated as safety issue: No ]
  • Proportion of eligible patients receiving fibrinolysis [ Time Frame: during hospitaliztion, an expected average of 10 days ] [ Designated as safety issue: No ]
  • door to needle time [ Time Frame: during hospitaliztion, an expected average of 10 days ] [ Designated as safety issue: No ]
  • proportion of patients evaluated for left ventricular failure [ Time Frame: during hospitaliztion, an expected average of 10 days ] [ Designated as safety issue: No ]
  • proportion of patients discharged on anti-platelet therapy/beta-blocker/statin/ACEI or ARB [ Time Frame: during hospitaliztion, an expected average of 10 days ] [ Designated as safety issue: No ]
  • hospital length of stay [ Time Frame: during hospitaliztion, an expected average of 10 days ] [ Designated as safety issue: No ]
  • proportion of patients with a final diagnosis consistent with ECG and biomarkers. [ Time Frame: during hospitaliztion, an expected average of 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20000
Study Start Date: July 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
Group A will receive quality care intervention in the first step
 Behavioral: quality improvement initiatives
Complex intervention including clinical pathway, performance measurement and feedback, and online education and support.
Group B
Group B will receive intervention in second stage of study.
 Behavioral: quality improvement initiatives
Complex intervention including clinical pathway, performance measurement and feedback, and online education and support.
Group C
Group C will recieve intervention at step 3 of the study.
 Behavioral: quality improvement initiatives
Complex intervention including clinical pathway, performance measurement and feedback, and online education and support.
Group D
Group D will receive intervention at stage 4 of the study
 Behavioral: quality improvement initiatives
Complex intervention including clinical pathway, performance measurement and feedback, and online education and support.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed as Acute Coronary Syndromes(ACS)
  • elder than 18 years

Exclusion Criteria:

  • death happened within 10 min arriving hospital
  • ACS happened during hospitalization due to other health problem
  • patients already registered in the database
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398228

Contacts
Contact: Xin Du, MD 86-010-82800577 ext 108 dxin@georgeinstitute.org.cn

Sponsors and Collaborators
The George Institute for Global Health, China
  More Information

No publications provided

Responsible Party: Lijing Yan, The George Institute for Global Health
ClinicalTrials.gov Identifier: NCT01398228     History of Changes
Other Study ID Numbers: CPACS-3
Study First Received: July 18, 2011
Last Updated: July 19, 2011
Health Authority: China: Ministry of Health

Keywords provided by The George Institute for Global Health, China:
Quality of care on ACS

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013