BMJ open · 2021
Comparison of antiangina therapies in patients with coronary heart disease in China: study protocol for a multicentre, retrospective, hospital system-based study.
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Li Ping, Chen Juan, Ke Zheng, Han Jing, Shen Lan, Zhou Ning
Аннотация
INTRODUCTION: China has the largest number of patients with coronary heart disease (CHD) in the world. Numerous pharmacological strategies are available for CHD in routine clinical practice. CHD-induced angina pectoris affects patients' quality of life and is a key predictor of prognosis. This study will compare the effectiveness of different antiangina treatments, particularly ATP-sensitive potassium channel (KATP) activators, in the Central China District. This proposal underpins the first comparison of antiangina therapies in patients with CHD in China using a multicentre, retrospective, hospital system-based assessment.
METHODS AND ANALYSIS: This retrospective real-world study will assess the largest hospital databases in Wuhan City in Central China to evaluate outcomes including mortality, revascularisation, myocardial infarction (MI), stroke and other cardio-cerebrovascular events in patients with CHD. Data will be consecutively collected between 1 April 2009 and 31 August 2019 through the hospital information system, laboratory information system and hospital imaging system. All data will be standardised by at least three independent technicians and statisticians using International Classification of Diseases Tenth Version, ISO15189 and Specification for Drafting of Basic Dataset of Electronic Medical Record (WS445). The data will include patient demographics, physical and laboratory examinations, imaging examinations, medical history, diagnosis, treatment options and payment information. We will compare KATP activators with other antiangina drugs using propensity score matching. The primary outcome will be major adverse cardiovascular events, defined as a composite of death, MI, stroke and rehospitalisation due to angina.
ETHICS AND DISSEMINATION: The current study is designed to translate research into improved care for patients. The institutional review board of Wuhan Tongji Hospital (Liao Jiazhi, Du Aiye, Chen Zhishui, Fang Feng, Yu Shiying, Liu Dong and Li Yaping) approved the study protocol (version 1.0, July 2019, approval number TJ-IRB201909112). Here we reported a protocol related to a pre-results. Data will be presented in peer-reviewed journals, social media and relevant conferences.
TRIAL REGISTRATION NUMBER: ChiCTR1900027812; Pre-results.
METHODS AND ANALYSIS: This retrospective real-world study will assess the largest hospital databases in Wuhan City in Central China to evaluate outcomes including mortality, revascularisation, myocardial infarction (MI), stroke and other cardio-cerebrovascular events in patients with CHD. Data will be consecutively collected between 1 April 2009 and 31 August 2019 through the hospital information system, laboratory information system and hospital imaging system. All data will be standardised by at least three independent technicians and statisticians using International Classification of Diseases Tenth Version, ISO15189 and Specification for Drafting of Basic Dataset of Electronic Medical Record (WS445). The data will include patient demographics, physical and laboratory examinations, imaging examinations, medical history, diagnosis, treatment options and payment information. We will compare KATP activators with other antiangina drugs using propensity score matching. The primary outcome will be major adverse cardiovascular events, defined as a composite of death, MI, stroke and rehospitalisation due to angina.
ETHICS AND DISSEMINATION: The current study is designed to translate research into improved care for patients. The institutional review board of Wuhan Tongji Hospital (Liao Jiazhi, Du Aiye, Chen Zhishui, Fang Feng, Yu Shiying, Liu Dong and Li Yaping) approved the study protocol (version 1.0, July 2019, approval number TJ-IRB201909112). Here we reported a protocol related to a pre-results. Data will be presented in peer-reviewed journals, social media and relevant conferences.
TRIAL REGISTRATION NUMBER: ChiCTR1900027812; Pre-results.