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

NCT ID: NCT01398228

Last Updated: 2016-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29934 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group 1

Group 1 will receive quality improvement initiatives first, after 6 months of baseline initiation.

Group Type OTHER

quality improvement initiatives

Intervention Type BEHAVIORAL

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.

Group 2

Group 2 will receive quality improvement initiatives second, after 6 months of the intervention initiation for Group 1.

Group Type OTHER

quality improvement initiatives

Intervention Type BEHAVIORAL

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.

Group 3

Group 3 will receive quality improvement initiatives third, after 6 months of the intervention initiation for Group 2.

Group Type OTHER

quality improvement initiatives

Intervention Type BEHAVIORAL

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.

Group 4

Group 4 will receive quality improvement initiatives forth, after 6 months of the intervention initiation for Group 3.

Group Type OTHER

quality improvement initiatives

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The George Institute for Global Health, China

OTHER

Sponsor Role lead

Responsible Party

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Yangfeng Wu

senior director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yangfeng Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

George Institute for global health, China

Locations

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Weining hospital

Bijie, Anhui, China

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Lixin people's hospital

Bozhou, Anhui, China

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Woyang people's hospital

Bozhou, Anhui, China

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Wuwei people's hospital

Chaohu, Anhui, China

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Yingshang people's hospital

Fuyang, Anhui, China

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Linquan people's hospital

Fuyang, Anhui, China

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Suixi people's hospital

Huaibei, Anhui, China

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Shucheng people's hospital

Liuan, Anhui, China

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Huoshang hospital

Liuan, Anhui, China

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Zhuanglang people's hospital

Dingxi, Gansu, China

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Gaolan people's hospital

Lanzhou, Gansu, China

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Jingning people's hospital

Pingliang, Gansu, China

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Zhuangliang people's hospital

Pingliang, Gansu, China

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Taishan people's hospital

Jiangmen, Guangdong, China

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Wuhua people's hospital

Meizhou, Guangdong, China

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Lianzhou people's hospital

Qingyuan, Guangdong, China

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Wuchuan people's hospital

Zhanjiang, Guangdong, China

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Pu'an people's hospital

Buwei, Guizhou, China

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Dejiang

Tongren, Guizhou, China

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Yuqing people's hospital

Zunyi, Guizhou, China

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Gaoyang hospital

Baoding, Hebei, China

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Tang county hospital

Baoding, Hebei, China

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Yi county hospital

Baoding, Hebei, China

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Weichang manchu mongolia atounomous county hospital

Chengde, Hebei, China

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Quzhou hospital

Handan, Hebei, China

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Jizhou hospital

Jizhou, Hebei, China

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Qinglong hospital

Qinhuangdao, Hebei, China

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Zanhuang hospital

Shijiazhuang, Hebei, China

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Shenze hospital

Shijiazhuang, Hebei, China

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Pingxiang people's hospital

Xingtai, Hebei, China

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Huaxian people's hospital

Anyang, Henan, China

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Wuzhi people's hospital

Jiaozuo, Henan, China

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Ruyang people's hospital

Luoyang, Henan, China

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Xixia people's hospital

Nanyang, Henan, China

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Chang huan hong li hospital

Xinxiang, Henan, China

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Shangcheng people's hospital

Xinyang, Henan, China

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Dancheng people's hospital

Zhoukou, Henan, China

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Pingyu people's hospital

Zhumadian, Henan, China

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Jianshi people's hospital

Enshi, Hubei, China

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Songzi people's hospital

Jinzhou, Hubei, China

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Danjiangkou's first hospital

Shiyan, Hubei, China

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Tongcheng people's hospital

Xian'ning, Hubei, China

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Gucheng people's hospital

Xiangyang, Hubei, China

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Yidu's first hospital

Yichang, Hubei, China

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Yingcheng people's hospital

Yingcheng, Hubei, China

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Zhongxiang people's hospital

Zhongxiang, Hubei, China

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Ba lin zuo qi people's hospital

Chifeng, Inner Mongolia, China

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A rong qi people's hospital

Hulin, Inner Mongolia, China

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Zha lu te people's hospital

Tongliao, Inner Mongolia, China

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Huolinguole hospital

Tongliao, Inner Mongolia, China

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DongHai people's hospital

Lianyungang, Jiangsu, China

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Dongtai people's hospital

Yancheng, Jiangsu, China

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Gaoyou people's hospital

Yangzhou, Jiangsu, China

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Tongyu people's hospital

Baicheng, Jilin, China

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Linjiang hospital

Baishan, Jilin, China

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Dong feng people's hospital

Liaoyuan, Jilin, China

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Qian'an hospital

Songyuan, Jilin, China

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Huinan people's hospital

Tonghua, Jilin, China

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Changbai montain protection and development zone central hospital

Yanbian, Jilin, China

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Hunchun people's hospital

Yanbian, Jilin, China

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Yitong 1st people's hospital

Yitong, Jilin, China

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Beipiao 1st people's hospital

Chaoyang, Liaoning, China

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Lingyuan people's hospital

Chaoyang, Liaoning, China

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Zhuanghe central hospital

Dalian, Liaoning, China

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Wafangdian people's hospital

Dalian, Liaoning, China

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Kuandian Manchu Autonomous County Central Hospital

Dandong, Liaoning, China

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Qingyuan Manchu Autonomous County people's hospital

Fushun, Liaoning, China

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Beizhen people's hospital

Jinzhou, Liaoning, China

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Changtu people's hospital

Tieling, Liaoning, China

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Fengxiang hospital

Baoji, Shaanxi, China

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Xixiang hospital

Hanzhong, Shaanxi, China

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Mian county hospital

Hanzhong, Shaanxi, China

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Fuping hospital

Weinan, Shaanxi, China

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Hancheng people's hospital

Weinan, Shaanxi, China

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Hu county hospital

Xi'an, Shaanxi, China

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Zichang hospital

Yan’an, Shaanxi, China

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Shenmu hospital

Yulin, Shaanxi, China

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Chengwu people's hospital

Heze, Shandong, China

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Pingyin people's hospital

Jinan, Shandong, China

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Dong'e people's hospital

Liaocheng, Shandong, China

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Yinan people's hospital

Linyi, Shandong, China

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Xintai people's hospital

Tai’an, Shandong, China

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Linqu people's hospital

Weifang, Shandong, China

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Penglai people's hospital

Yantai, Shandong, China

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Huantai people's hospital

Zibo, Shandong, China

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Changzhi steel and iron group head hospital

Changzhi, Shanxi, China

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Qingyuan people's hospital

Changzhi, Shanxi, China

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Hunyuan people's hospital

Datong, Shanxi, China

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Gaoping people's hospital

Jincheng, Shanxi, China

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Lingshi people's hospital

Jinzhong, Shanxi, China

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Pu xian people's hospital

Linfen, Shanxi, China

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Xiangfen people's hospital

Linfen, Shanxi, China

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Guxian people's hospital

Linfen, Shanxi, China

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Yicheng people's hospital

Linfen, Shanxi, China

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Lou fan people's hospital

Taiyuan, Shanxi, China

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Houma people's hospital

Xintian, Shanxi, China

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Yuanping people's hospital

Xinzhou, Shanxi, China

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Huanqu people's hospital

Yuncheng, Shanxi, China

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Dazhu people's hospital

Dazhou, Sichuan, China

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Cangxi people's hospital

Guangyuan, Sichuan, China

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Mianning people's hospital

Liangshan, Sichuan, China

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Xuyong people's hospital

Luzhou, Sichuan, China

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Countries

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China

References

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Xie G, Patel A, Du X, Sun Y, Li X, Wu T, Hao Z, Gao R, Wu Y. Impact of In-Hospital Quality of Care Improvement Initiative on Secondary Prevention of Acute Coronary Syndrome in Six Months After Patient Discharge: A Large Stepped Wedge- and Cluster-Randomized Controlled Trial. Circ Cardiovasc Qual Outcomes. 2025 May;18(5):e011441. doi: 10.1161/CIRCOUTCOMES.124.011441. Epub 2025 Apr 4.

Reference Type DERIVED
PMID: 40184150 (View on PubMed)

Xie W, Patel A, Boersma E, Feng L, Li M, Gao R, Wu Y. Chronic kidney disease and the outcomes of fibrinolysis for ST-segment elevation myocardial infarction: A real-world study. PLoS One. 2021 Jan 19;16(1):e0245576. doi: 10.1371/journal.pone.0245576. eCollection 2021.

Reference Type DERIVED
PMID: 33465135 (View on PubMed)

Sun Y, Feng L, Li X, Gao R, Wu Y. The sex difference in 6-month MACEs and its explaining variables in acute myocardial infarction survivors: Data from CPACS-3 study. Int J Cardiol. 2020 Jul 15;311:1-6. doi: 10.1016/j.ijcard.2020.03.043. Epub 2020 Mar 20.

Reference Type DERIVED
PMID: 32223960 (View on PubMed)

Feng L, Li M, Xie W, Zhang A, Lei L, Li X, Gao R, Wu Y. Prehospital and in-hospital delays to care and associated factors in patients with STEMI: an observational study in 101 non-PCI hospitals in China. BMJ Open. 2019 Nov 10;9(11):e031918. doi: 10.1136/bmjopen-2019-031918.

Reference Type DERIVED
PMID: 31712344 (View on PubMed)

Wu Y, Li S, Patel A, Li X, Du X, Wu T, Zhao Y, Feng L, Billot L, Peterson ED, Woodward M, Kong L, Huo Y, Hu D, Chalkidou K, Gao R; CPACS-3 Investigators. Effect of a Quality of Care Improvement Initiative in Patients With Acute Coronary Syndrome in Resource-Constrained Hospitals in China: A Randomized Clinical Trial. JAMA Cardiol. 2019 May 1;4(5):418-427. doi: 10.1001/jamacardio.2019.0897.

Reference Type DERIVED
PMID: 30994898 (View on PubMed)

Li S, Wu Y, Du X, Li X, Patel A, Peterson ED, Turnbull F, Lo S, Billot L, Laba T, Gao R; CPACS-3 investigators. Rational and design of a stepped-wedge cluster randomized trial evaluating quality improvement initiative for reducing cardiovascular events among patients with acute coronary syndromes in resource-constrained hospitals in China. Am Heart J. 2015 Mar;169(3):349-55. doi: 10.1016/j.ahj.2014.12.005. Epub 2014 Dec 18.

Reference Type DERIVED
PMID: 25728724 (View on PubMed)

Other Identifiers

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CPACS-3

Identifier Type: -

Identifier Source: org_study_id

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