Left Ventricular Myocardial Work for Predicting Response to CRT

NCT ID: NCT07319065

Last Updated: 2026-01-06

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

NOT_YET_RECRUITING

Total Enrollment

3240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-12-31

Brief Summary

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This study aims to establish the normal reference values for left ventricular myocardial work in healthy Chinese adults and the influencing factors. Non-invasive myocardial work serves as a new parameter for identifying CRT responders and provides a scoring system for predicting the efficacy of CRT in clinical practice. CRT can improve cardiac function and quality of life, and reduce mortality and hospitalization rates due to heart failure (HF). Currently, the number of CRT treatments is increasing year by year, but even when strictly following the indications, approximately 30% of patients do not respond. Therefore, precise prediction of CRT efficacy is of great clinical significance for improving prognosis. Currently, the indications for CRT mainly rely on clinical, electrocardiogram (CLBBB), and LVEF. By correcting ventricular contraction asynchrony to improve systolic function, however, CLBBB indicates electrical asynchrony, and LVEF improvement depends on mechanical synchrony. If the mechanical asynchrony of the ventricles can be evaluated directly before surgery, it will help predict the efficacy of CRT. Myocardial work is a recently developed non-invasive method that combines LV afterload with the overall longitudinal strain (GLS) analysis of echocardiography. Myocardial work reflects the contraction ability of the heart, stroke work, residual myocardial contraction ability, myocardial oxygen consumption, useless work, useful work, etc., and is represented by the pressure-volume loop analysis, thus having the potential to predict the efficacy of CRT. Therefore, this study intends to adopt the left ventricular myocardial work technique, combined with the current indication criteria, to predict the long-term efficacy of patients with heart failure who are scheduled for CRT treatment, thereby increasing the response rate of CRT and improving the prognosis of patients. Currently, there are no normal reference values for left ventricular myocardial work in healthy Chinese adults. Therefore, our center has initiated this multicenter clinical research project, collaborating with multiple ultrasound centers across the country, aiming to establish the normal ultrasound values for left ventricular myocardial work in healthy Chinese adults, providing new quantitative reference basis for the diagnosis of myocardial function, assessment of the severity of myocardial lesions, and efficacy observation.

Detailed Description

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Conditions

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CRT Non-Response LBBB HF - Heart Failure Healthy Adult

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Adults Group

Healthy adults aged 18 to 79 years are planned to be stratified into 6 age groups: 18-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years, and ≥70 years. Each age group will include 120 participants of each sex.

No interventions assigned to this group

Patients with heart failure and left bundle branch block who are scheduled to undergo CRT treatment

Ultrasound machine LVEF ≤ 35%; QRS ≥ 150ms; LBBB; Optimal drug therapy for at least 3 months before implantation 600 participants

Ultrasound machine

Intervention Type DIAGNOSTIC_TEST

Myocardial work is a recently developed non-invasive method that incorporates the LV afterload into the overall longitudinal strain (GLS) analysis of echocardiography. Myocardial work reflects the contractile ability of the heart, stroke work per beat, residual myocardial contractile ability, myocardial oxygen consumption, useless work, and useful work, which is represented by the pressure-volume loop analysis and thus has the potential to predict the efficacy of CRT.

Patients with LBBB who have preserved LVEF

LVEF≥53%; LBBB 600 participants

Ultrasound machine

Intervention Type DIAGNOSTIC_TEST

Myocardial work is a recently developed non-invasive method that incorporates the LV afterload into the overall longitudinal strain (GLS) analysis of echocardiography. Myocardial work reflects the contractile ability of the heart, stroke work per beat, residual myocardial contractile ability, myocardial oxygen consumption, useless work, and useful work, which is represented by the pressure-volume loop analysis and thus has the potential to predict the efficacy of CRT.

Patients with reduced LVEF but without LBBB

LVEF ≤ 35%, non-LBBB 600 participants

Ultrasound machine

Intervention Type DIAGNOSTIC_TEST

Myocardial work is a recently developed non-invasive method that incorporates the LV afterload into the overall longitudinal strain (GLS) analysis of echocardiography. Myocardial work reflects the contractile ability of the heart, stroke work per beat, residual myocardial contractile ability, myocardial oxygen consumption, useless work, and useful work, which is represented by the pressure-volume loop analysis and thus has the potential to predict the efficacy of CRT.

Interventions

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Ultrasound machine

Myocardial work is a recently developed non-invasive method that incorporates the LV afterload into the overall longitudinal strain (GLS) analysis of echocardiography. Myocardial work reflects the contractile ability of the heart, stroke work per beat, residual myocardial contractile ability, myocardial oxygen consumption, useless work, and useful work, which is represented by the pressure-volume loop analysis and thus has the potential to predict the efficacy of CRT.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Participants must meet all of the following criteria to be enrolled:

1. Of Han Chinese ethnicity
2. Aged 18-79 years
3. Normal blood pressure (\< 140/90 mmHg)
4. Normal fasting blood glucose
5. Normal blood lipid levels (triglycerides, total cholesterol, low-density lipoprotein, high-density lipoprotein)
6. Normal complete blood count results (hemoglobin concentration, white blood cell count, red blood cell count, platelet count)
7. Normal liver and renal function (alanine transaminase \< 2× upper limit of normal; normal creatinine and blood urea nitrogen)
8. Normal electrocardiogram results (occasional atrial premature beats may be enrolled at the investigator's discretion)
9. No structural heart disease and normal cardiac function confirmed by echocardiography


1. LVEF ≤ 35%
2. QRS ≥ 150ms; LBBB
3. At least 3 months of optimal drug therapy before implantation


1. LVEF≥53%
2. LBBB


1. LVEF ≤ 35%
2. non-LBBB

Exclusion Criteria

Participants will be excluded if they meet any of the following criteria:

1. Clinically significant cardiac valve regurgitation (≥ mild severity)
2. Respiratory diseases: acute or chronic respiratory disorders
3. Endocrine diseases: thyroid disease, diabetes mellitus, hyperaldosteronism, pheochromocytoma, etc.
4. Abnormal liver function (alanine transaminase \> 2× upper limit of normal), abnormal renal function (elevated creatinine beyond normal range), or dyslipidemia (elevated triglycerides, total cholesterol, low-density lipoprotein, or high-density lipoprotein)
5. Other systemic diseases: anemia, malignancy, connective tissue disease, large artery/peripheral vascular diseases (aortic dilation, aortic dissection, coarctation of the aorta, Takayasu arteritis, atherosclerosis), etc.
6. Pregnant or lactating women
7. Professional athletes
8. Poor-quality ultrasound images that cannot support parameter measurement and analysis

Heart failure patients with LBBB who are scheduled for CRT treatment Group


1. Suffering from connective tissue diseases such as systemic lupus erythematosus, polymyositis, and rheumatoid arthritis;
2. Having a history of blood diseases and severe systemic diseases such as infections;
3. Those who cannot cooperate with the examinations.

Patients with LBBB who have preserved LVEF Group


1. Suffering from connective tissue diseases such as systemic lupus erythematosus, polymyositis, and rheumatoid arthritis;
2. Having a history of blood diseases and severe systemic diseases such as infections;
3. Those who cannot cooperate with the examinations.

Patients with reduced LVEF but without LBBB Group


1. Suffering from connective tissue diseases such as systemic lupus erythematosus, polymyositis, and rheumatoid arthritis;
2. Having a history of blood diseases and severe systemic diseases such as infections;
3. Those who cannot cooperate with the examinations.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Hospital of China Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chunyan Ma

Chief of Cardiovascular Ultrasound

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chunyan Ma, MD

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

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Anhui University of Chinese Medicine First Affiliated Hospital

Hefei, Anhui, China

Site Status

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

The First Affiliated Hospital of Wannan Medical College

Wannan, Anhui, China

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The Provincial Hospital Affiliated to Fuzhou University

Fuzhou, Fujian, China

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Fujian Provincial Geriatric Hospital

Guizhou, Fujian, China

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Guizhou Provincial People's Hospital

Guizhou, Fujian, China

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Union Hospital Affiliated to Fujian Medical University

Guizhou, Fujian, China

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The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

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Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

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Gansu Provincial People's Hospital

Lanzhou, Gansu, China

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Jiangmen Central Hospital

Jiangmen, Guangdong, China

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The First Hospital of Qinhuangdao City

Qinhuangdao, Hebei, China

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The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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Longnan Hospital of Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

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The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

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The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Heinan, China

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FuWai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

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The First Affiliated Hospital of Henan Medical University (Xinxiang Medical University)

Zhengzhou, Henan, China

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The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

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Enshi Central Hospital

Enshi, Hubei, China

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Puai Hospital of Wuhan City / The Fourth Hospital of Wuhan City

Wuhan, Hubei, China

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Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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Xiangyang Hospital of Traditional Chinese Medicine, Hubei Province

Xiangyang, Hubei, China

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Changzhou Second People's Hospital

Changzhou, Jiangsu, China

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The First People's Hospital of Lianyungang City

Lianyungang, Jiangsu, China

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Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

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The First People's Hospital of Nantong City

Nantong, Jiangsu, China

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The Third People's Hospital of Nantong City

Nantong, Jiangsu, China

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Suqian Hospital of Jiangsu Provincial People's Hospital

Suqian, Jiangsu, China

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The Hospital of Traditional Chinese Medicine of Suzhou City

Suzhou, Jiangsu, China

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The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

The Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

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The People's Hospital of Wuxi City

Wuxi, Jiangsu, China

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Su Bei People's Hospital

Yangzhou, Jiangsu, China

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The First Affiliated Hospital of Guizhou Medical University

Guizhoucun, Jiangxi, China

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The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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The First Hospital of Jilin University

Jilin, Jilin, China

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The Second Hospital of Jilin University

Jilin, Jilin, China

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Central Hospital of Anshan City

Anshan, Liaoning, China

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The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

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The First Hospital of China Medical University

Shenyang, Liaoning, China

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Liaoning Golden Autumn Hospital

Shenyang, Liaoning, China

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Shengjing Hospital, China Medical University

Shenyang, Liaoning, China

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Chifeng Hospital

Chifeng, Neimenggu, China

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The People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

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Jinan Central Hospital

Jinan, Shandong, China

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The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

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The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Bethea Hospital of Shanxi Province

Taiyuan, Shanxi, China

Site Status

Shanxi Cardiovascular Hospital (Shanxi Cardiovascular Hospital Research Institute)

Taiyuan, Shanxi, China

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The Cancer Hospital of Shanxi Province

Taiyuan, Shanxi, China

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The People's Hospital of Shanxi Province

Taiyuan, Shanxi, China

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Tangdu Hospital, Air Force Medical University

Xi’an, Shanxi, China

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The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

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The People's Hospital of Sichuan Province

Chengdu, Sichuan, China

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Xindu District People's Hospital of Chengdu City

Chengdu, Sichuan, China

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Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

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The People's Hospital of Ya'an City

Ya'an, Sichuan, China

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Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine / The Fourth Affiliated Hospital of Xinjiang Medical University

Xinjiang, Xinjiang, China

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Dianxi Central Hospital of Yunnan Province

Dingxi, Yunnan, China

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The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

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Yan'an Hospital of Kunming City

Kunming, Yunnan, China

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Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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Lihuili Hospital of Ningbo Medical Center

Ningbo, Zhejiang, China

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The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

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The Second Hospital of Ningbo City

Ningbo, Zhejiang, China

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The Second Hospital of Shaoxing City

Shaoxing, Zhejiang, China

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Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

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The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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The People's Hospital of Zhuji City

Zhuji, Zhejiang, China

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The First Hospital of Peking University

Beijing, , China

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The First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

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The Second Affiliated Hospital of Chongqing Medical University

Chongqing, , China

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Shanghai Chest Hospital

Shanghai, , China

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The First Affiliated Hospital of Xinjiang Medical University

Xinjiang, , China

Site Status

Countries

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China

Central Contacts

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Chunyan Ma, MD

Role: CONTACT

+86 13998816448

Facility Contacts

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Jie Zhang

Role: primary

Xuegong Shi

Role: primary

Yuanyuan Ji

Role: primary

Yan Zhang

Role: primary

Ming Li

Role: primary

Ying Li

Role: primary

Jinguo Li

Role: primary

Yan Ge

Role: primary

Guohui Yan

Role: primary

Yuanyuan Chu

Role: primary

Zhongzhou Su

Role: primary

Chong Zhao

Role: primary

Chang Lv

Role: primary

Ming Liu

Role: primary

Ling Zhang

Role: primary

Ning Yang

Role: primary

Xin Zhang

Role: primary

Lin Liu

Role: primary

Juan Cong

Role: primary

Ran Li

Role: primary

Fei Wang

Role: primary

Kaiquan Wang

Role: primary

Bingyi Zhang

Role: primary

Yani Liu

Role: primary

Yuman Li

Role: primary

Wei Shi

Role: primary

Chang Liu

Role: primary

Yan Wang

Role: primary

Yonghong Yong

Role: primary

Li Ma

Role: primary

Hui Liu

Role: primary

Huijun Lai

Role: primary

Changsheng Ma

Role: primary

Qi Sun

Role: primary

Dajun Qian

Role: primary

Yong Chen

Role: primary

Sha Li

Role: primary

Xinchun Yuan

Role: primary

Yong Qian

Role: primary

Dongmei Lv

Role: primary

Yao Wang

Role: primary

Tao Cong

Role: primary

Chunyan Ma, MD

Role: primary

+8613998816448

Chunyan Ma, MD

Role: backup

Jianfeng Cao

Role: primary

Lin Gao

Role: primary

Zhiying Cheng

Role: primary

Lihua Jin

Role: primary

Haiyan Wang

Role: primary

Yan Wen

Role: primary

Tianliang Li

Role: primary

Tianliang Li

Role: primary

Runqin Miao

Role: primary

Weiqin Li

Role: primary

Lianbi Zhao

Role: primary

Huanhuan Huo

Role: primary

Li Li

Role: primary

Yi Zhang

Role: primary

Jie Fang

Role: primary

Sha Tang

Role: primary

Yong Zhou

Role: primary

Yu Wang

Role: primary

Zhe Meng

Role: primary

Pei Wang

Role: primary

Yan Cheng

Role: primary

Wei Wu

Role: primary

Shengmin Zhang

Role: primary

Kai Zheng

Role: primary

Gang Wang

Role: primary

Shusheng Liao

Role: primary

Yu Yang

Role: primary

Ying Yang

Role: primary

Qian Dong

Role: primary

Yang Sun

Role: primary

Fan Li

Role: primary

Lina Guan

Role: primary

Other Identifiers

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General Electric Healthcare

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CARE-MW Study

Identifier Type: -

Identifier Source: org_study_id

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