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NCT04399447 Clinical Trial

Multicenter Normal Reference Study of Tissue Motion Tracking of Mitral Annular Displacement(TMAD)

Healthy Volunteers Clinical Trial

— TMAD  

Official title:
The Multi-center Normal Reference Study of Tissue Motion Tracking of Mitral Annular Displacement(TMAD) in Chinese Han Adults Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04399447
Other study ID # ShengJing Hospital Ultrasound
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2020
Est. completion date September 30, 2021

Study information
Verified date May 2020
Source Shengjing Hospital
Contact Weidong Ren
Phone 8618940251657
Email renwd01@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To establish the range of TMADmid、TMADmidpt% by using tissue motion tracking of mitral annular displacement (TMAD), and to explore the influencing factors.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2400
Est. completion date September 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 79 Years
Eligibility Inclusion Criteria:

1. Han nationality

2. Ages 18-79.

3. Normal body mass index (18-25kg / m2).

4. Normal blood pressure (139-90 / 89-60mmHg).

5. No history of cardiovascular and respiratory diseases.

6. No abnormality was found in physical examination of cardiovascular and respiratory system.

7. Blood glucose, lipid profile and electrocardiogram were normal.

8. Echocardiography showed no structural heart disease and normal heart function.

9. No history of medications affecting cardiovascular system.

Exclusion Criteria:

1. Clinically significant or moderate heart valve regurgitation.

2. Respiratory diseases: acute or chronic respiratory diseases.

3. Endocrine diseases: thyroid disease, diabetes, hyperaldosteronism, pheochromocytoma, and abnormal adrenal function.

4. Anemia.

5. Pregnant or lactating women.

6. 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).

7. Connective tissue disease.

8. Tumor.

9. Aortic and peripheral vascular diseases: aortic dilatation, aortic dissection, aortic constriction, multiple arteritis, and atherosclerosis.

10. Drink more than 50ml of white wine daily; more than 100ml of red wine; more than 300ml of beer.

11. Professional athletes.

12. The poor quality of the ultrasound image cannot satisfy the parameter measurement and analysis.

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Echocardiography
left ventricular systolic function of all participants were measured by tissue motion tracking of mitral annular displacement using PHILIPS

Locations
Country Name City State
China Baicheng Central Hospital Baicheng Jilin
China Affiliated Hospital of YouJiang Medical University for Nationalities Baise Guangxi
China People'S Hospital of Baise Baise Guangxi
China Gansu Baiyin Second People's Hospital Baiyin Gansu
China Baoji Central Hospital Baoji Shanxi
China The First Affiliated Hospital of Baotou Medical College Baotou Inner Mongolia
China Benxi Central Hospital Benxi Liaoning
China People'S Hospital of Hunan Province Changsha Hunan
China Chaoyang Central Hospital Chaoyang Liaoning
China The Peoplep'S Hospital of Wenjiang District,Chengdu Chendu Sichuan
China Fengning Manchu Autonomous County Hospital Chengde Hebei
China Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Chengdu Sichuan
China Chengdu First People's Hospital Chengdu Sichuan
China Chengdu Second People'S Hospital Chengdu Sichuan
China Chengdu Third People's Hospital Chengdu Sichuan
China Chongqing University Cancer Hospital Chongqing Chongqing
China The People'S Hospital of Chong Zuo Chongzuo Guangxi
China Dali Bai Autonomous Prefecture People'S Hospital Dali Yunnan
China Dalian Municipal Central Hospital Dalian Liaoning
China The First Affiliated Hospital of Dalian Medical University Dalian Liaoning
China The Second Affiliated Hospital of Dalian Medical University Dalian Liaoning
China DanDong central hospital Dandong Liaoning
China The First People's Hospital of Foshan City Foshan Guangdong
China Fuchun Central Hospital Fushun Liaoning
China General Hospital of Fushun Mining Bureau Fushun Liaoning
China The People's Hospital of Gaozhou Gaozhou Guangdong
China West China-Guang'An Hospital,Sichuan University Guang'an Sichuan
China the Second Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou Guangdong
China Guigang City People'S Hospital Guigang Guangxi
China The First Affiliated Hospital of Hainan Medical University Haikou Hainan
China Handan First Hospital Handan Hebei
China Hanzhong Central Hospital Hanzhong Shanxi
China Anhui Provincial Hospital Hefei Anhui
China The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia
China The First People's Hospital of Huaihua Huaihua Hunan
China Jilin Central General Hospital Jilin Jilin
China The Second Hospital of Shandong University Jinan Shandong
China The First Affiliated Hospital of Jinzhou Medical University Jinzhou Liaoning
China Jiujiang University Affiliated Hospital Jiujiang Jiangxi
China Laibin People's Hospital Laibin Guangxi
China The People's Hospital Of Leshan Leshan Sichuan
China Liaocheng People'S Hospital Liaocheng Shandong
China The Affiliated Hospital of Southwest Medical University Luzhou Sichuan
China Mudanjiang Cardiovascular Hospital Mudanjiang Heilongjiang
China Affiliated Hospital of North Sichuan Medical College Nanchong Sichuan
China Nanchong Central Hospital Nanchong Sichuan
China Guangxi International Zhuang Medical Hospital Nanning Guangxi
China Guangxi Minzu Hospital Nanning Guangxi
China Nanyang Second People's Hospital Nanyang Henan
China Panzhihua Central Hospital Panzhihua Sichuan
China Qingyuan People's Hospital Qingyuan Guangdong
China The Third Affiliated Hospital of Qiqihar Medical Hospital Qiqihar Heilongjiang
China Shanghai Pudong New District Zhoupu Hospital Shanghai Shanghai
China Central Hospital Affiliated To ShenYang Medical College Shenyang Liaoning
China Shengjing Hospital of China Medical University Shenyang Liaoning
China The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang Liaoning
China The First Hospital of China Medical University Shenyang Liaoning
China The People'S Hospital of Liaoning Province Shenyang Liaoning
China the Second Affiliated Hospital Of Shenyang Medical College Shenyang Liaoning
China First Affiliated Hospital,School of Medical,Shihezi University Shihezi Xinjiang
China shijiazhuang No.1 Hospital Shijiazhuang Hebei
China The Fourth Hospital of Heibei Medical University Hebei Cancer Hospital Shijiazhuang Hebei
China Suining Central Hospital Suining Sichuan
China Tangshan fengnan district hospital Tangshan Hebei
China Urumqi Friendship Hospital Urumqi Xinjiang
China Shaanxi Provincial People'S Hospital Xi'an Shanxi
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China Xianyang Central Hospital Xianyang Shanxi
China Xingtai Third Hospital Xingtai Hebei
China Qinghai Provincial People's Hospital Xining Qinghai
China Yantai Affiliated Hospital of Binzhou Medical University Yantai Shandong
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China The first peopel's hospital of yulin Yulin Guangxi
China Zibo City Linzi District People's Hospital Zibo Shandong

Sponsors (1)
Lead Sponsor Collaborator
Weidong Ren

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other Serum biochemical index 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
Primary left ventricular systolic function was measured by tissue motion tracking of mitral annular displacement(TMAD) To establish the range of TMADmid by using TMAD 1 day
Primary left ventricular systolic function was measured by tissue motion tracking of mitral annular displacement(TMAD) To establish the range of TMADmidpt% by using TMAD 1 day
Secondary left ventricular systolic function was measured by the two-plane Simpson method the left ventricular ejection fraction measured by the two-plane Simpson method, is the standard of the clinical 1 day
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