MedPath

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

Conditions
Healthy Volunteers
Left Ventricular Systolic Dysfunction
Interventions
Radiation: Echocardiography
Registration Number
NCT04399447
Lead Sponsor
Weidong Ren
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
2400
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
30-39 year-old groupEchocardiographyBased 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.
18-29 year-old groupEchocardiographyBased 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.
60-69 year-old groupEchocardiographyBased 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.
70-79 year-old groupEchocardiographyBased 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.
50-59 year-old groupEchocardiographyBased 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.
40-49 year-old groupEchocardiographyBased 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.
Primary Outcome Measures
NameTimeMethod
left ventricular systolic function was measured by tissue motion tracking of mitral annular displacement(TMAD)1 day

To establish the range of TMADmidpt% by using TMAD

Secondary Outcome Measures
NameTimeMethod
left ventricular systolic function was measured by the two-plane Simpson method1 day

the left ventricular ejection fraction measured by the two-plane Simpson method, is the standard of the clinical

Trial Locations

Locations (75)

Anhui Provincial Hospital

🇨🇳

Hefei, Anhui, China

Chongqing University Cancer Hospital

🇨🇳

Chongqing, Chongqing, China

The People's Hospital of Gaozhou

🇨🇳

Gaozhou, Guangdong, China

Qingyuan People's Hospital

🇨🇳

Qingyuan, Guangdong, China

People'S Hospital of Baise

🇨🇳

Baise, Guangxi, China

Guigang City People'S Hospital

🇨🇳

Guigang, Guangxi, China

Guangxi International Zhuang Medical Hospital

🇨🇳

Nanning, Guangxi, China

The first peopel's hospital of yulin

🇨🇳

Yulin, Guangxi, China

Fengning Manchu Autonomous County Hospital

🇨🇳

Chengde, Hebei, China

Handan First Hospital

🇨🇳

Handan, Hebei, China

Tangshan fengnan district hospital

🇨🇳

Tangshan, Hebei, China

Xingtai Third Hospital

🇨🇳

Xingtai, Hebei, China

Nanyang Second People's Hospital

🇨🇳

Nanyang, Henan, China

People'S Hospital of Hunan Province

🇨🇳

Changsha, Hunan, China

The First People's Hospital of Huaihua

🇨🇳

Huaihua, Hunan, China

Jiujiang University Affiliated Hospital

🇨🇳

Jiujiang, Jiangxi, China

Baicheng Central Hospital

🇨🇳

Baicheng, Jilin, China

Jilin Central General Hospital

🇨🇳

Jilin, Jilin, China

The First Affiliated Hospital of Dalian Medical University

🇨🇳

Dalian, Liaoning, China

Benxi Central Hospital

🇨🇳

Benxi, Liaoning, China

Chaoyang Central Hospital

🇨🇳

Chaoyang, Liaoning, China

Dalian Municipal Central Hospital

🇨🇳

Dalian, Liaoning, China

The Second Affiliated Hospital of Dalian Medical University

🇨🇳

Dalian, Liaoning, China

Fuchun Central Hospital

🇨🇳

Fushun, Liaoning, China

General Hospital of Fushun Mining Bureau

🇨🇳

Fushun, Liaoning, China

The First Affiliated Hospital of Jinzhou Medical University

🇨🇳

Jinzhou, Liaoning, China

Shengjing Hospital of China Medical University

🇨🇳

Shenyang, Liaoning, China

Central Hospital Affiliated To ShenYang Medical College

🇨🇳

Shenyang, Liaoning, China

Hanzhong Central Hospital

🇨🇳

Hanzhong, Shanxi, China

the Second Affiliated Hospital Of Shenyang Medical College

🇨🇳

Shenyang, Liaoning, China

Zibo City Linzi District People's Hospital

🇨🇳

Zibo, Shandong, China

Shaanxi Provincial People'S Hospital

🇨🇳

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

The Peoplep'S Hospital of Wenjiang District,Chengdu

🇨🇳

Chendu, Sichuan, China

Chengdu Second People'S Hospital

🇨🇳

Chengdu, Sichuan, China

Chengdu Third People's Hospital

🇨🇳

Chengdu, Sichuan, China

West China-Guang'An Hospital,Sichuan University

🇨🇳

Guang'an, Sichuan, China

The Affiliated Hospital of Southwest Medical University

🇨🇳

Luzhou, Sichuan, China

Affiliated Hospital of North Sichuan Medical College

🇨🇳

Nanchong, Sichuan, China

Nanchong Central Hospital

🇨🇳

Nanchong, Sichuan, China

Panzhihua Central Hospital

🇨🇳

Panzhihua, Sichuan, China

Suining Central Hospital

🇨🇳

Suining, Sichuan, China

First Affiliated Hospital,School of Medical,Shihezi University

🇨🇳

Shihezi, Xinjiang, China

Urumqi Friendship Hospital

🇨🇳

Urumqi, Xinjiang, China

The First People's Hospital of Foshan City

🇨🇳

Foshan, Guangdong, China

Gansu Baiyin Second People's Hospital

🇨🇳

Baiyin, Gansu, China

the Second Affiliated Hospital of Guangzhou University of Chinese Medicine

🇨🇳

Guangzhou, Guangdong, China

Affiliated Hospital of YouJiang Medical University for Nationalities

🇨🇳

Baise, Guangxi, China

The People'S Hospital of Chong Zuo

🇨🇳

Chongzuo, Guangxi, China

Laibin People's Hospital

🇨🇳

Laibin, Guangxi, China

Guangxi Minzu Hospital

🇨🇳

Nanning, Guangxi, China

The First Affiliated Hospital of Hainan Medical University

🇨🇳

Haikou, Hainan, China

shijiazhuang No.1 Hospital

🇨🇳

Shijiazhuang, Hebei, China

The Fourth Hospital of Heibei Medical University Hebei Cancer Hospital

🇨🇳

Shijiazhuang, Hebei, China

Mudanjiang Cardiovascular Hospital

🇨🇳

Mudanjiang, Heilongjiang, China

The Third Affiliated Hospital of Qiqihar Medical Hospital

🇨🇳

Qiqihar, Heilongjiang, China

The Affiliated Hospital of Inner Mongolia Medical University

🇨🇳

Hohhot, Inner Mongolia, China

The First Affiliated Hospital of Baotou Medical College

🇨🇳

Baotou, Inner Mongolia, China

DanDong central hospital

🇨🇳

Dandong, Liaoning, China

The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

🇨🇳

Shenyang, Liaoning, China

The People'S Hospital of Liaoning Province

🇨🇳

Shenyang, Liaoning, China

Qinghai Provincial People's Hospital

🇨🇳

Xining, Qinghai, China

General Hospital of Ningxia Medical University

🇨🇳

Yinchuan, Ningxia, China

The Second Hospital of Shandong University

🇨🇳

Jinan, Shandong, China

Liaocheng People'S Hospital

🇨🇳

Liaocheng, Shandong, China

Yantai Affiliated Hospital of Binzhou Medical University

🇨🇳

Yantai, Shandong, China

Baoji Central Hospital

🇨🇳

Baoji, Shanxi, China

Shanghai Pudong New District Zhoupu Hospital

🇨🇳

Shanghai, Shanghai, China

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

🇨🇳

Chengdu, Sichuan, China

Chengdu First People's Hospital

🇨🇳

Chengdu, Sichuan, China

The People's Hospital Of Leshan

🇨🇳

Leshan, Sichuan, China

Dali Bai Autonomous Prefecture People'S Hospital

🇨🇳

Dali, Yunnan, China

The First Hospital of China Medical University

🇨🇳

Shenyang, Liaoning, China

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