- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04399447
Multicenter Normal Reference Study of Tissue Motion Tracking of Mitral Annular Displacement(TMAD) (TMAD)
The Multi-center Normal Reference Study of Tissue Motion Tracking of Mitral Annular Displacement(TMAD) in Chinese Han Adults Study
Study Overview
Status
Intervention / Treatment
Detailed Description
With the gradual aging of Chinese population and continuous development of economy and society, the incidence of cardiovascular disease and the number of patients have increased rapidly. The National Heart Center has reported that the number of patients with clinically diagnosed cardiovascular disease in China has reached 290 million in 2016 (240 million in 2014). Cardiovascular disease is the most common cause of death in humans. Left ventricular systolic function plays an important role in the treatment and prognosis of patients with myocardial diseases. Early sensitive detection of left ventricular systolic function, timely treatment and early evaluation of the therapeutic effect can greatly reduce the death of patients with myocardial diseases rate.
At present, the left ventricular ejection fraction (LVEF), measured by the two-plane Simpson method in clinical, is one of the methods to evaluating left ventricular systolic function. It is especially suitable for patients with geometric deformation of the left ventricle, but some early heart failure patients' LVEF is still in the normal range, whose systolic function has been reduced, but. In recent years, 2D longitudinal strain is one of the indicators for evaluating left ventricular systolic function. The researchers believe that 70% of cardiac function is obtained by longitudinal movement of myocardium , which can be used as a good indicator for identifying myocardial diseases. However, both the two-plane Simpson method and the 2D longitudinal strain require good sound transmission conditions and good image quality. You can clearly see the endocardium and epicardium. Not all of patients in the clinic can get better image.
Basic and clinical studies and clinical statistics show that tissue motion tracking of mitral annular displacement (TMAD) is not affected by image quality and can effectively evaluate left ventricular systolic function. It can measure the mitral valve annulus displacement by marking the mitral valve annulus point and the reference point, which can quickly and accurately evaluate the left ventricular longitudinal contraction function.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Anhui
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Hefei, Anhui, China
- Recruiting
- Anhui Provincial Hospital
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Contact:
- Haoyi Yang
- Phone Number: 13720360838
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Principal Investigator:
- Haoyi Yang
-
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Chongqing
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Chongqing, Chongqing, China
- Recruiting
- Chongqing University Cancer Hospital
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Contact:
- Fang Li
- Phone Number: 13808312288
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Principal Investigator:
- Fang Li
-
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Gansu
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Baiyin, Gansu, China
- Recruiting
- Gansu Baiyin Second People's Hospital
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Contact:
- Xinjian Yang
- Phone Number: 13619308289
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Principal Investigator:
- Xinjian Yang
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Guangdong
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Foshan, Guangdong, China
- Recruiting
- The First People's Hospital of Foshan City
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Contact:
- Yuqiong Lai
- Phone Number: 13809859038
-
Principal Investigator:
- Yuqiong Lai
-
Gaozhou, Guangdong, China
- Recruiting
- The People's Hospital of Gaozhou
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Contact:
- Guoxiong Wei
- Phone Number: 13580011299
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Principal Investigator:
- Guoxiong Wei
-
Guangzhou, Guangdong, China
- Recruiting
- The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
-
Contact:
- Pengtao Sun
- Phone Number: 18620168536
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Principal Investigator:
- Pengtao Sun
-
Qingyuan, Guangdong, China
- Recruiting
- Qingyuan People's Hospital
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Contact:
- Liwen Wu
- Phone Number: 13802896000
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Principal Investigator:
- Liwen Wu
-
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Guangxi
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Baise, Guangxi, China
- Recruiting
- Affiliated Hospital of Youjiang Medical University for Nationalities
-
Contact:
- Chengcai Chen
- Phone Number: 13977617591
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Principal Investigator:
- Chengcai Chen
-
Baise, Guangxi, China
- Recruiting
- People's Hospital of Baise
-
Contact:
- Maoyi Li
- Phone Number: 18677628852
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Principal Investigator:
- Maoyi Li
-
Chongzuo, Guangxi, China
- Recruiting
- The People'S Hospital of Chong Zuo
-
Contact:
- Mei Li
- Phone Number: 13807873360
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Principal Investigator:
- Mei Li
-
Guigang, Guangxi, China
- Recruiting
- Guigang City People's Hospital
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Contact:
- Zongxin Tao
- Phone Number: 13737559953
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Principal Investigator:
- Zongxin Tao
-
Laibin, Guangxi, China
- Recruiting
- Laibin People's Hospital
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Contact:
- Xianling Mo
- Phone Number: 18907828711
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Principal Investigator:
- Xianling Mo
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Nanning, Guangxi, China
- Recruiting
- Guangxi International Zhuang Medical Hospital
-
Contact:
- Minhua Chen
- Phone Number: 13517689974
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Principal Investigator:
- Minhua Chen
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Nanning, Guangxi, China
- Recruiting
- Guangxi Minzu Hospital
-
Contact:
- Haiqing Su
- Phone Number: 13978827211
-
Principal Investigator:
- Haiqing Su
-
Yulin, Guangxi, China
- Recruiting
- The first peopel's hospital of yulin
-
Contact:
- Hongxia Yin
- Phone Number: 18977585936
-
Principal Investigator:
- Hongxia Yin
-
-
Hainan
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Haikou, Hainan, China
- Recruiting
- The First Affiliated Hospital of Hainan Medical University
-
Contact:
- Ruixia Nan
- Phone Number: 13036006449
-
Principal Investigator:
- Ruixia Nan
-
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Hebei
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Chengde, Hebei, China
- Recruiting
- Fengning Manchu Autonomous County Hospital
-
Contact:
- Dongsheng Zhao
- Phone Number: 13483872058
-
Principal Investigator:
- Dongsheng Zhao
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Handan, Hebei, China
- Recruiting
- Handan First Hospital
-
Contact:
- Shaobo Wang
- Phone Number: 15631006699
-
Principal Investigator:
- Shaobo Wang
-
Shijiazhuang, Hebei, China
- Recruiting
- shijiazhuang No.1 Hospital
-
Contact:
- Xiaoqing Yang
- Phone Number: 17603119685
-
Principal Investigator:
- Xiaoqing Yang
-
Shijiazhuang, Hebei, China
- Recruiting
- The Fourth Hospital of Heibei Medical University Hebei Cancer Hospital
-
Contact:
- Xiaohong Gong
- Phone Number: 13831110712
-
Principal Investigator:
- Xiaohong Gong
-
Tangshan, Hebei, China
- Recruiting
- Tangshan Fengnan District Hospital
-
Contact:
- Yihong Li
- Phone Number: 19931565611
-
Principal Investigator:
- Yihong Li
-
Xingtai, Hebei, China
- Recruiting
- Xingtai Third Hospital
-
Contact:
- Hongbing Peng
- Phone Number: 13131991001
-
Principal Investigator:
- Hongbing Peng
-
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Heilongjiang
-
Mudanjiang, Heilongjiang, China
- Recruiting
- Mudanjiang Cardiovascular Hospital
-
Contact:
- Guangyu Gao
- Phone Number: 13704838773
-
Principal Investigator:
- Guangyu Gao
-
Qiqihar, Heilongjiang, China
- Recruiting
- The Third Affiliated Hospital of Qiqihar Medical Hospital
-
Contact:
- Xiao Liang
- Phone Number: 13846283727
-
Principal Investigator:
- Xiao Liang
-
-
Henan
-
Nanyang, Henan, China
- Recruiting
- Nanyang Second People's Hospital
-
Contact:
- Xu meng Ding
- Phone Number: 13503779799
-
Principal Investigator:
- Xu meng Ding
-
-
Hunan
-
Changsha, Hunan, China
- Recruiting
- People's Hospital of Hunan Province
-
Contact:
- Kun Ao
- Phone Number: 13467511183
-
Principal Investigator:
- Kun Ao
-
Huaihua, Hunan, China
- Recruiting
- The First People's Hospital of Huaihua
-
Contact:
- Rui Zhang
- Phone Number: 13973099796
-
Principal Investigator:
- Rui Zhang
-
-
Inner Mongolia
-
Baotou, Inner Mongolia, China
- Recruiting
- The First Affiliated Hospital of Baotou Medical College
-
Contact:
- Guozhen Yan
- Phone Number: 18547218068
-
Principal Investigator:
- Guozhen Yan
-
Hohhot, Inner Mongolia, China
- Recruiting
- The Affiliated Hospital of Inner Mongolia Medical University
-
Contact:
- Xiaoshan Zhang
- Phone Number: 13947133133
-
Principal Investigator:
- Xiaoshan Zhang
-
-
Jiangxi
-
Jiujiang, Jiangxi, China
- Recruiting
- Jiujiang University Affiliated Hospital
-
Contact:
- Xuehua Xiao
- Phone Number: 13517920820
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Principal Investigator:
- Xuehua Xiao
-
-
Jilin
-
Baicheng, Jilin, China
- Recruiting
- Baicheng Central Hospital
-
Contact:
- Fan Zhang
- Phone Number: 13943623116
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Principal Investigator:
- Fan Zhang
-
Jilin, Jilin, China
- Recruiting
- Jilin Central General Hospital
-
Contact:
- Bing Gong
- Phone Number: 15543430477
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Principal Investigator:
- Bing Gong
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Liaoning
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Benxi, Liaoning, China
- Recruiting
- Benxi Central Hospital
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Contact:
- Xingbin Wang
- Phone Number: 18941435757
-
Principal Investigator:
- Xingbin Wang
-
Chaoyang, Liaoning, China
- Recruiting
- Chaoyang Central Hospital
-
Contact:
- Suli Zhang
- Phone Number: 18040159891
-
Principal Investigator:
- Suli Zhang
-
Dalian, Liaoning, China, 116011
- Recruiting
- The First Affiliated Hospital of Dalian Medical University
-
Contact:
- Tao Cong
- Phone Number: 18098875836
-
Principal Investigator:
- Tao Cong
-
Dalian, Liaoning, China, 116033
- Recruiting
- Dalian Municipal Central Hospital
-
Contact:
- Xiaofang Pan
- Phone Number: 13591327871
-
Principal Investigator:
- Xiaofang Pan
-
Dalian, Liaoning, China
- Recruiting
- The Second Affiliated Hospital of Dalian Medical University
-
Contact:
- Jun Wu
- Phone Number: 13942022794
-
Principal Investigator:
- Jun Wu
-
Dandong, Liaoning, China
- Recruiting
- Dandong Central Hospital
-
Contact:
- Xin Jin
- Phone Number: 13842580705
-
Principal Investigator:
- Xin Jin
-
Fushun, Liaoning, China
- Recruiting
- Fuchun Central Hospital
-
Contact:
- Chen Zhang
- Phone Number: 13941314545
-
Principal Investigator:
- Chen Zhang
-
Fushun, Liaoning, China
- Recruiting
- General Hospital of Fushun Mining Bureau
-
Contact:
- Chunfeng Wang
- Phone Number: 15694239647
-
Principal Investigator:
- Chunfeng Wang
-
Jinzhou, Liaoning, China
- Recruiting
- The First Affiliated Hospital of Jinzhou Medical University
-
Contact:
- Yuhong Li
- Phone Number: 13940637604
-
Principal Investigator:
- Yuhong Li
-
Shenyang, Liaoning, China
- Recruiting
- The First Hospital of China Medical University
-
Principal Investigator:
- jun Yang
-
Contact:
- Jun Yang
- Phone Number: 13840266962
-
Shenyang, Liaoning, China, 110004
- Recruiting
- Shengjing Hospital Of China Medical University
-
Contact:
- Weidong Ren
- Phone Number: 18940251657
- Email: renwd01@163.com
-
Principal Investigator:
- Lu Sun
-
Shenyang, Liaoning, China
- Recruiting
- Central Hospital Affiliated to Shenyang Medical College
-
Contact:
- Tong Zang
- Phone Number: 18002477367
-
Principal Investigator:
- Tong Zang
-
Shenyang, Liaoning, China
- Recruiting
- The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
-
Contact:
- Linwei Hong
- Phone Number: 18040041999
-
Principal Investigator:
- Linwei Hong
-
Shenyang, Liaoning, China
- Recruiting
- The People's Hospital of Liaoning Province
-
Contact:
- Fang Zhu
- Phone Number: 17702485777
-
Shenyang, Liaoning, China
- Recruiting
- The Second Affiliated Hospital of Shenyang Medical College
-
Contact:
- Jie Liu
- Phone Number: 18002452866
-
Principal Investigator:
- Jie Liu
-
-
Ningxia
-
Yinchuan, Ningxia, China
- Recruiting
- General Hospital of Ningxia Medical University
-
Contact:
- Lisha Na
- Phone Number: 13995376025
-
Principal Investigator:
- Lisha Na
-
-
Qinghai
-
Xining, Qinghai, China
- Recruiting
- Qinghai Provincial People's Hospital
-
Contact:
- Haixia Sun
- Phone Number: 18597015698
-
Principal Investigator:
- Haixia Sun
-
-
Shandong
-
Jinan, Shandong, China
- Recruiting
- The Second Hospital of Shandong University
-
Contact:
- Yongmei Wang
- Phone Number: 15153169591
-
Principal Investigator:
- Yongmei Wang
-
Liaocheng, Shandong, China
- Recruiting
- Liaocheng People's Hospital
-
Contact:
- Yilin Liu
- Phone Number: 13346251883
-
Principal Investigator:
- Yilin Liu
-
Yantai, Shandong, China
- Recruiting
- Yantai Affiliated Hospital of Binzhou Medical University
-
Contact:
- Jiange Li
- Phone Number: 18363805900
-
Principal Investigator:
- Jiange Li
-
Zibo, Shandong, China
- Recruiting
- Zibo City Linzi District People's Hospital
-
Contact:
- Ying Liu
- Phone Number: 17660292589
-
-
Shanghai
-
Shanghai, Shanghai, China
- Recruiting
- Shanghai Pudong New District Zhoupu Hospital
-
Contact:
- Ye Song
- Phone Number: 13818086439
-
Principal Investigator:
- Ye Song
-
-
Shanxi
-
Baoji, Shanxi, China
- Recruiting
- Baoji Central Hospital
-
Contact:
- Guoliang Dun
- Phone Number: 13509176168
-
Principal Investigator:
- Guoliang Dun
-
Hanzhong, Shanxi, China
- Recruiting
- Hanzhong Central Hospital
-
Contact:
- Zipeng Liu
- Phone Number: 13084899536
-
Principal Investigator:
- Zipeng Liu
-
Xi'an, Shanxi, China
- Recruiting
- The Second Affiliated Hospital of Xi'an Jiaotong University
-
Principal Investigator:
- Qi Zhou
-
Contact:
- Qi Zhou
- Phone Number: 18966896600
-
Xi'an, Shanxi, China
- Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Contact:
- Shun Wang
- Phone Number: 18991232635
-
Principal Investigator:
- Shun Wang
-
Xi'an, Shanxi, China
- Recruiting
- Shaanxi Provincial People's Hospital
-
Contact:
- Xiangping Guan
- Phone Number: 13991979638
-
Principal Investigator:
- Xiangping Guan
-
Xianyang, Shanxi, China
- Recruiting
- Xianyang Central Hospital
-
Contact:
- Lei Cui
- Phone Number: 13809141343
-
Principal Investigator:
- Lei Cui
-
-
Sichuan
-
Chendu, Sichuan, China
- Recruiting
- The Peoplep'S Hospital of Wenjiang District,Chengdu
-
Contact:
- Jing Tan
- Phone Number: 13708204839
-
Principal Investigator:
- Jing Tan
-
Chengdu, Sichuan, China
- Recruiting
- Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
-
Contact:
- Yu Kang
-
Principal Investigator:
- Yu Kang
-
Chengdu, Sichuan, China
- Recruiting
- Chengdu First People's Hospital
-
Contact:
- Xinyun Chen
- Phone Number: 18011390127
-
Principal Investigator:
- Xinyun Chen
-
Chengdu, Sichuan, China
- Recruiting
- Chengdu Second People's Hospital
-
Contact:
- Yun Shi
- Phone Number: 13658051337
-
Principal Investigator:
- Yun Shi
-
Chengdu, Sichuan, China
- Recruiting
- Chengdu Third People's Hospital
-
Contact:
- Feng Xiong
-
Principal Investigator:
- Feng Xiong
-
Guang'an, Sichuan, China
- Recruiting
- West China-Guang'An Hospital,Sichuan University
-
Contact:
- Shuwen Chen
- Phone Number: 13550980666
-
Principal Investigator:
- Shuwen Chen
-
Leshan, Sichuan, China
- Recruiting
- The people's hospital of Leshan
-
Contact:
- Ying Liu
- Phone Number: 17628182552
-
Luzhou, Sichuan, China
- Recruiting
- The affiliated hospital of Southwest Medical University
-
Contact:
- Jizhu Xia
- Phone Number: 18715770806
-
Principal Investigator:
- Jizhu Xia
-
Nanchong, Sichuan, China
- Recruiting
- Affiliated Hospital of North Sichuan Medical College
-
Contact:
- Wensheng Yue
- Phone Number: 13690767960
-
Principal Investigator:
- Wensheng Yue
-
Nanchong, Sichuan, China
- Recruiting
- Nanchong Central Hospital
-
Contact:
- Xuebin Liu
- Phone Number: 15882613551
-
Principal Investigator:
- Xuebin Liu
-
Panzhihua, Sichuan, China
- Recruiting
- Panzhihua Central Hospital
-
Contact:
- Xiaoli Wu
- Phone Number: 13982323405
-
Principal Investigator:
- Xiaoli Wu
-
Suining, Sichuan, China
- Recruiting
- Suining Central Hospital
-
Contact:
- Xiaoyong Luo
- Phone Number: 18008258086
-
Principal Investigator:
- Xiaoyong Luo
-
-
Xinjiang
-
Shihezi, Xinjiang, China
- Recruiting
- First Affiliated Hospital,School of Medical,Shihezi University
-
Contact:
- Guilin Lu
- Phone Number: 13899527866
-
Principal Investigator:
- Guilin Lu
-
Urumqi, Xinjiang, China
- Recruiting
- Urumqi Friendship Hospital
-
Contact:
- Baoling Wang
- Phone Number: 13579235938
-
Principal Investigator:
- Baoling Wang
-
-
Yunnan
-
Dali, Yunnan, China
- Recruiting
- Dali Bai Autonomous Prefecture People's Hospital
-
Contact:
- Yan Cui
- Phone Number: 13987275528
-
Principal Investigator:
- Yan Cui
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Han nationality
- Ages 18-79.
- Normal body mass index (18-25kg / m2).
- Normal blood pressure (139-90 / 89-60mmHg).
- No history of cardiovascular and respiratory diseases.
- No abnormality was found in physical examination of cardiovascular and respiratory system.
- Blood glucose, lipid profile and electrocardiogram were normal.
- Echocardiography showed no structural heart disease and normal heart function.
- No history of medications affecting cardiovascular system.
Exclusion Criteria:
- Clinically significant or moderate heart valve regurgitation.
- Respiratory diseases: acute or chronic respiratory diseases.
- Endocrine diseases: thyroid disease, diabetes, hyperaldosteronism, pheochromocytoma, and abnormal adrenal function.
- Anemia.
- Pregnant or lactating women.
- Abnormal liver function (glutamyl aminotransferase exceeds 2.0 times the upper limit of normal value), abnormal renal function (creatinine exceeds the normal value), increased blood lipids (triglycerides, total cholesterol, low density and high density lipoprotein, any of which is higher than Normal value).
- Connective tissue disease.
- Tumor.
- Aortic and peripheral vascular diseases: aortic dilatation, aortic dissection, aortic constriction, multiple arteritis, and atherosclerosis.
- Drink more than 50ml of white wine daily; more than 100ml of red wine; more than 300ml of beer.
- Professional athletes.
- The poor quality of the ultrasound image cannot satisfy the parameter measurement and analysis.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
18-29 year-old group
Based on the inclusion crtiteria, 200 healthy Han people at aged 18-29 and both sexes will be recruited in the analysis.
Normal reference values of tissue motion tracking of mitral annular displacement will be obtained.
|
left ventricular systolic function of all participants were measured by tissue motion tracking of mitral annular displacement using PHILIPS
|
|
30-39 year-old group
Based on the inclusion crtiteria, 200 healthy Han people at aged 30-39 and both sexes will be recruited in the analysis.
Normal reference values of tissue motion tracking of mitral annular displacement will be obtained.
|
left ventricular systolic function of all participants were measured by tissue motion tracking of mitral annular displacement using PHILIPS
|
|
40-49 year-old group
Based on the inclusion crtiteria, 200 healthy Han people at aged 40-49 and both sexes will be recruited in the analysis.
Normal reference values of tissue motion tracking of mitral annular displacement will be obtained.
|
left ventricular systolic function of all participants were measured by tissue motion tracking of mitral annular displacement using PHILIPS
|
|
50-59 year-old group
Based on the inclusion crtiteria, 200 healthy Han people at aged 50-59 and both sexes will be recruited in the analysis.
Normal reference values of tissue motion tracking of mitral annular displacement will be obtained.
|
left ventricular systolic function of all participants were measured by tissue motion tracking of mitral annular displacement using PHILIPS
|
|
60-69 year-old group
Based on the inclusion crtiteria, 200 healthy Han people at aged 60-69 and both sexes will be recruited in the analysis.
Normal reference values of tissue motion tracking of mitral annular displacement will be obtained.
|
left ventricular systolic function of all participants were measured by tissue motion tracking of mitral annular displacement using PHILIPS
|
|
70-79 year-old group
Based on the inclusion crtiteria, 200 healthy Han people at aged 70-79 and both sexes will be recruited in the analysis.
Normal reference values of tissue motion tracking of mitral annular displacement will be obtained.
|
left ventricular systolic function of all participants were measured by tissue motion tracking of mitral annular displacement using PHILIPS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
left ventricular systolic function was measured by tissue motion tracking of mitral annular displacement(TMAD)
Time Frame: 1 day
|
To establish the range of TMADmid by using TMAD
|
1 day
|
|
left ventricular systolic function was measured by tissue motion tracking of mitral annular displacement(TMAD)
Time Frame: 1 day
|
To establish the range of TMADmidpt% by using TMAD
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
left ventricular systolic function was measured by the two-plane Simpson method
Time Frame: 1 day
|
the left ventricular ejection fraction measured by the two-plane Simpson method, is the standard of the clinical
|
1 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum biochemical index
Time Frame: 1 day
|
Serum laboratory testing for blood cholesterol level (total cholesterol, HDL (high-density lipoprotein), LDL (low-density lipoproteins), triglycerides), fasting blood-glucose will be examed.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Weidong Ren, Shengjing Hospital of China Medical Univeristy
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ShengJing Hospital Ultrasound
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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