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

August 8, 2016 updated by: Yangfeng Wu, The George Institute for Global Health, China

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

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 104 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29934

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bijie, Anhui, China, 553100
        • Weining hospital
      • Bozhou, Anhui, China, 236700
        • Lixin people's hospital
      • Bozhou, Anhui, China, 236700
        • Woyang people's hospital
      • Chaohu, Anhui, China, 238300
        • Wuwei People's Hospital
      • Fuyang, Anhui, China, 236200
        • Yingshang people's hospital
      • Fuyang, Anhui, China, 236400
        • Linquan people's hospital
      • Huaibei, Anhui, China, 235100
        • Suixi people's hospital
      • Liuan, Anhui, China, 231300
        • Shucheng People's Hospital
      • Liuan, Anhui, China, 237200
        • Huoshang hospital
    • Gansu
      • Dingxi, Gansu, China, 730500
        • Zhuanglang people's hospital
      • Lanzhou, Gansu, China, 730200
        • Gaolan people's hospital
      • Pingliang, Gansu, China, 743400
        • Jingning people's hospital
      • Pingliang, Gansu, China, 744600
        • Zhuangliang people's hospital
    • Guangdong
      • Jiangmen, Guangdong, China, 529200
        • Taishan people's Hospital
      • Meizhou, Guangdong, China, 514400
        • Wuhua people's hospital
      • Qingyuan, Guangdong, China, 513300
        • Lianzhou People's Hospital
      • Zhanjiang, Guangdong, China, 524500
        • Wuchuan People's Hospital
    • Guizhou
      • Buwei, Guizhou, China, 561500
        • Pu'an people's hospital
      • Tongren, Guizhou, China, 565200
        • Dejiang
      • Zunyi, Guizhou, China, 564400
        • Yuqing people's hospital
    • Hebei
      • Baoding, Hebei, China, 071500
        • Gaoyang hospital
      • Baoding, Hebei, China, 072300
        • Tang county hospital
      • Baoding, Hebei, China, 074200
        • Yi county hospital
      • Chengde, Hebei, China, 068400
        • Weichang manchu mongolia atounomous county hospital
      • Handan, Hebei, China, 057200
        • Quzhou hospital
      • Jizhou, Hebei, China, 053200
        • Jizhou hospital
      • Qinhuangdao, Hebei, China, 066500
        • Qinglong hospital
      • Shijiazhuang, Hebei, China, 051200
        • Zanhuang hospital
      • Shijiazhuang, Hebei, China, 052500
        • Shenze hospital
      • Xingtai, Hebei, China, 054500
        • Pingxiang People's Hospital
    • Henan
      • Anyang, Henan, China, 456400
        • Huaxian People's Hospital
      • Jiaozuo, Henan, China, 454950
        • Wuzhi people's hospital
      • Luoyang, Henan, China, 471200
        • Ruyang People's Hospital
      • Nanyang, Henan, China, 474500
        • Xixia people's hospital
      • Xinxiang, Henan, China, 453000
        • Chang huan hong li hospital
      • Xinyang, Henan, China, 465300
        • Shangcheng people's hospital
      • Zhoukou, Henan, China, 477100
        • Dancheng People's Hospital
      • Zhumadian, Henan, China, 463400
        • Pingyu People's Hospital
    • Hubei
      • Enshi, Hubei, China, 445300
        • Jianshi people's hospital
      • Jinzhou, Hubei, China, 434200
        • Songzi People's Hospital
      • Shiyan, Hubei, China, 442700
        • Danjiangkou's first hospital
      • Xian'ning, Hubei, China, 437400
        • Tongcheng people's hospital
      • Xiangfan, Hubei, China, 441700
        • Gucheng People's Hospital
      • Yichang, Hubei, China, 443300
        • Yidu's first hospital
      • Yingcheng, Hubei, China, 432400
        • Yingcheng People's Hospital
      • Zhongxiang, Hubei, China, 431900
        • Zhongxiang People's Hospital
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China, 025400
        • Ba lin zuo qi people's hospital
      • Hulin, Inner Mongolia, China, 162700
        • A rong qi people's hospital
      • Tongliao, Inner Mongolia, China, 029100
        • Zha lu te people's hospital
      • Tongliao, Inner Mongolia, China, 029200
        • Huolinguole hospital
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222300
        • DongHai people's hospital
      • Yancheng, Jiangsu, China, 224200
        • Dongtai People'S Hospital
      • Yangzhou, Jiangsu, China, 225600
        • Gaoyou people's hospital
    • Jilin
      • Baicheng, Jilin, China, 137000
        • Tongyu people's hospital
      • Baishan, Jilin, China, 134600
        • Linjiang hospital
      • Liaoyuan, Jilin, China, 136300
        • Dong feng people's hospital
      • Songyuan, Jilin, China, 131400
        • Qian'an hospital
      • Tonghua, Jilin, China, 135100
        • Huinan people's hospital
      • Yanbian, Jilin, China, 133000
        • Changbai montain protection and development zone central hospital
      • Yanbian, Jilin, China, 133300
        • Hunchun people's hospital
      • Yitong, Jilin, China, 130700
        • Yitong 1st people's hospital
    • Liaoning
      • Chaoyang, Liaoning, China, 122000
        • Beipiao 1st people's hospital
      • Chaoyang, Liaoning, China, 122500
        • Lingyuan people's hospital
      • Dalian, Liaoning, China, 116200
        • Zhuanghe central hospital
      • Dalian, Liaoning, China, 116300
        • Wafangdian people's hospital
      • Dandong, Liaoning, China, 118200
        • Kuandian Manchu Autonomous County Central Hospital
      • Fushun, Liaoning, China, 113300
        • Qingyuan Manchu Autonomous County people's hospital
      • Jinzhou, Liaoning, China, 122000
        • Beizhen people's hospital
      • Tieling, Liaoning, China, 112500
        • Changtu people's hospital
    • Shaanxi
      • Baoji, Shaanxi, China, 721400
        • Fengxiang hospital
      • Hanzhong, Shaanxi, China, 723500
        • Xixiang hospital
      • Hanzhong, Shaanxi, China, 724200
        • Mian county hospital
      • Weinan, Shaanxi, China, 711700
        • Fuping hospital
      • Weinan, Shaanxi, China, 714200
        • Hancheng people's hospital
      • Xi'an, Shaanxi, China, 710300
        • Hu county hospital
      • Yan'an, Shaanxi, China, 717300
        • Zichang hospital
      • Yulin, Shaanxi, China, 719300
        • Shenmu Hospital
    • Shandong
      • Heze, Shandong, China, 274200
        • Chengwu people's hospital
      • Jinan, Shandong, China, 250400
        • Pingyin people's hospital
      • Liaocheng, Shandong, China, 252200
        • Dong'e people's hospital
      • Linyi, Shandong, China, 276300
        • Yinan people's hospital
      • Tai'an, Shandong, China, 271200
        • Xintai People's Hospital
      • Weifang, Shandong, China, 262600
        • Linqu people's hospital
      • Yantai, Shandong, China, 265600
        • Penglai People's Hospital
      • Zibo, Shandong, China, 256400
        • Huantai people's hospital
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Changzhi steel and iron group head hospital
      • Changzhi, Shanxi, China, 046500
        • Qingyuan People's Hospital
      • Datong, Shanxi, China, 037400
        • Hunyuan people's hospital
      • Houma, Shanxi, China, 043000
        • Houma People's Hospital
      • Jincheng, Shanxi, China, 048400
        • Gaoping People's Hospital
      • Jinzhong, Shanxi, China, 031300
        • Lingshi people's hospital
      • Linfen, Shanxi, China, 041200
        • Pu xian people's hospital
      • Linfen, Shanxi, China, 041500
        • Xiangfen people's hospital
      • Linfen, Shanxi, China, 042400
        • Guxian people's hospital
      • Linfen, Shanxi, China, 043500
        • Yicheng people's hospital
      • Taiyuan, Shanxi, China, 030300
        • Lou fan people's hospital
      • Xinzhou, Shanxi, China, 034100
        • Yuanping people's hospital
      • Yuncheng, Shanxi, China, 043700
        • Huanqu people's hospital
    • Sichuan
      • Dazhou, Sichuan, China, 635100
        • Dazhu people's hospital
      • Guangyuan, Sichuan, China, 628400
        • Cangxi people's hospital
      • Liangshan, Sichuan, China, 615600
        • Mianning people's hospital
      • Luzhou, Sichuan, China, 464400
        • Xuyong people's hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • admitted to participating hospitals
  • diagnosed as Acute Coronary Syndromes(ACS) at the time of death or discharge
  • aged 18 years or older

Exclusion Criteria:

  • death happened within 10 mins after arriving hospital
  • ACS happened during hospitalization due to other health problem
  • patients already registered in the database

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Group 1
Group 1 will receive quality improvement initiatives first, after 6 months of baseline initiation.
Behavioral: quality improvement initiatives
A six component quality improvement intervention will be implemented. These components include: establishment of a quality improvement team, hospital performance audit and feedback, implementation of a clinical pathway, training of physicians and nurses, online technical support and patient education.
Other: Group 2
Group 2 will receive quality improvement initiatives second, after 6 months of the intervention initiation for Group 1.
Behavioral: quality improvement initiatives
A six component quality improvement intervention will be implemented. These components include: establishment of a quality improvement team, hospital performance audit and feedback, implementation of a clinical pathway, training of physicians and nurses, online technical support and patient education.
Other: Group 3
Group 3 will receive quality improvement initiatives third, after 6 months of the intervention initiation for Group 2.
Behavioral: quality improvement initiatives
A six component quality improvement intervention will be implemented. These components include: establishment of a quality improvement team, hospital performance audit and feedback, implementation of a clinical pathway, training of physicians and nurses, online technical support and patient education.
Other: Group 4
Group 4 will receive quality improvement initiatives forth, after 6 months of the intervention initiation for Group 3.
Behavioral: quality improvement initiatives
A six component quality improvement intervention will be implemented. These components include: establishment of a quality improvement team, hospital performance audit and feedback, implementation of a clinical pathway, training of physicians and nurses, online technical support and patient education.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
incidence rate of in-hospital major adverse cardiovascular events (MACE)
Time Frame: from hospitaliztion to 1 week after discharge
In-hospital major adverse cardiovascular events (MACE) comprising all-cause mortality, myocardial infarction or recurrent myocardial infarction and non-fatal stroke.The in-hospital mortality will include patients who deid during hospitalization, patients who gave up treatment and home and die within 1 week after returning home, and patients transfer to superior hospitals but die within one day.
from hospitaliztion to 1 week after discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
in-hospital all cause deaths
Time Frame: from hospitaliztion to 1 week after discharge
The in-hospital mortality will include patients who deid during hospitalization, patients who gave up treatment and home and die within 1 week after returning home, and patients transfer to superior hospitals but die within one day.
from hospitaliztion to 1 week after discharge
a patient level composite score calculated by KPIs of ACS care
Time Frame: During Hospitalization, an expected average of 10 days
A patient-level composite score is formed by dividing the total number of 15 pre-defined binary KPIs a patient receives by the total sum of KPIs a patient is eligible to receive. 15 KPI include: receive the first ECG within 10 minutes after arrival, receive aspirin within 24 hours of arrival, receive clopidogrel within 24 hours of arrival, receive statin within 24 hours of arrival, prescribe aspirin at discharge, prescribed clopidogrel at discharge, prescribed beta-blocker at discharge, prescribed statin at discharge, LVSD prescribed ACEI or ARB at discharge, STEMI that arrive hospital within 12 hours of symptom onset receive fibrinolysis, STEMI that received fibrinolytic therapy received this within 30 minutes of arrival, final diagnosis consistent with ECG and biomarker findings, receive both aspirin and clopidogrel within 24 hours, patient receive both aspirin and clopidogrel with loading dose within 24 hours, patient receive statin with loading dose within 24 hours.
During Hospitalization, an expected average of 10 days
each of the 16 KPIs (patient level)
Time Frame: During hospitalization, an expected average of 10 days
receive the first ECG within 10 minutes after arrival, receive aspirin within 24 hours of arrival, receive clopidogrel within 24 hours of arrival, receive statin within 24 hours of arrival, prescribe aspirin at discharge, prescribed clopidogrel at discharge, prescribed beta-blocker at discharge, prescribed statin at discharge, LVSD prescribed ACEI or ARB at discharge, STEMI that arrive hospital within 12 hours of symptom onset receive fibrinolysis, STEMI that received fibrinolytic therapy received this within 30 minutes of arrival, final diagnosis consistent with ECG and biomarker findings, receive both aspirin and clopidogrel within 24 hours, patient receive both aspirin and clopidogrel with loading dose within 24 hours, patient receive statin with loading dose within 24 hours and length of stay.
During hospitalization, an expected average of 10 days
a composite of MACE and re-hospitalization due to cardiovascular disease within 6 months after discharge
Time Frame: in 6 months after discharge
in 6 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The George Institute for Global Health, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yangfeng Wu, PhD, George Institute for global health, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPACS-3

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