Clinical trial NCT04399447: Multicenter Normal Reference Study of Tissue Motion Tracking of Mitral Annular Displacement(TMAD)
Official title: The Multi-center Normal Reference Study of Tissue Motion Tracking of Mitral Annular Displacement(TMAD) in Chinese Han Adults Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Left Ventricular Systolic Dysfunction
Healthy Volunteers
Keywords: systolic function
left ventricular
normal
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 2400 healthy adults with normal physical examination items will be selected from the physical examination center. According to sex and age stratification, totally 2400 cases will contain 1200 males and 1200 females. From 18 to 79 years old, they will be divided into 6 groups: 18-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years and 70-79 years (n=400 per group).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: left ventricular systolic function was measured by tissue motion tracking of mitral annular displacement（TMAD）
timeFrame: 1 day
measure: left ventricular systolic function was measured by tissue motion tracking of mitral annular displacement（TMAD）
timeFrame: 1 day
Secondary outcomes:
measure: left ventricular systolic function was measured by the two-plane Simpson method
timeFrame: 1 day
Other outcomes:
measure: Serum biochemical index
timeFrame: 1 day
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Baiyin
country: China
facility: Gansu Baiyin Second People's Hospital
state: Gansu
city: Foshan
country: China
facility: The First People's Hospital of Foshan City
state: Guangdong
city: Gaozhou
country: China
facility: The People's Hospital of Gaozhou
state: Guangdong
city: Guangzhou
country: China
facility: the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Qingyuan
country: China
facility: Qingyuan People's Hospital
state: Guangdong
city: Baise
country: China
facility: Affiliated Hospital of YouJiang Medical University for Nationalities
state: Guangxi
city: Baise
country: China
facility: People'S Hospital of Baise
state: Guangxi
city: Chongzuo
country: China
facility: The People'S Hospital of Chong Zuo
state: Guangxi
city: Guigang
country: China
facility: Guigang City People'S Hospital
state: Guangxi
city: Laibin
country: China
facility: Laibin People's Hospital
state: Guangxi
city: Nanning
country: China
facility: Guangxi International Zhuang Medical Hospital
state: Guangxi
city: Nanning
country: China
facility: Guangxi Minzu Hospital
state: Guangxi
city: Yulin
country: China
facility: The first peopel's hospital of yulin
state: Guangxi
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical University
state: Hainan
city: Chengde
country: China
facility: Fengning Manchu Autonomous County Hospital
state: Hebei
city: Handan
country: China
facility: Handan First Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: shijiazhuang No.1 Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Heibei Medical University Hebei Cancer Hospital
state: Hebei
city: Tangshan
country: China
facility: Tangshan fengnan district hospital
state: Hebei
city: Xingtai
country: China
facility: Xingtai Third Hospital
state: Hebei
city: Mudanjiang
country: China
facility: Mudanjiang Cardiovascular Hospital
state: Heilongjiang
city: Qiqihar
country: China
facility: The Third Affiliated Hospital of Qiqihar Medical Hospital
state: Heilongjiang
city: Nanyang
country: China
facility: Nanyang Second People's Hospital
state: Henan
city: Changsha
country: China
facility: People'S Hospital of Hunan Province
state: Hunan
city: Huaihua
country: China
facility: The First People's Hospital of Huaihua
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Jiujiang
country: China
facility: Jiujiang University Affiliated Hospital
state: Jiangxi
city: Baicheng
country: China
facility: Baicheng Central Hospital
state: Jilin
city: Jilin
country: China
facility: Jilin Central General Hospital
state: Jilin
city: Benxi
country: China
facility: Benxi Central Hospital
state: Liaoning
city: Chaoyang
country: China
facility: Chaoyang Central Hospital
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
state: Liaoning
city: Dalian
country: China
facility: The Second Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dandong
country: China
facility: DanDong central hospital
state: Liaoning
city: Fushun
country: China
facility: Fuchun Central Hospital
state: Liaoning
city: Fushun
country: China
facility: General Hospital of Fushun Mining Bureau
state: Liaoning
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Central Hospital Affiliated To ShenYang Medical College
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The People'S Hospital of Liaoning Province
state: Liaoning
city: Shenyang
country: China
facility: the Second Affiliated Hospital Of Shenyang Medical College
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xining
country: China
facility: Qinghai Provincial People's Hospital
state: Qinghai
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People'S Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Affiliated Hospital of Binzhou Medical University
state: Shandong
city: Zibo
country: China
facility: Zibo City Linzi District People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Pudong New District Zhoupu Hospital
state: Shanghai
city: Baoji
country: China
facility: Baoji Central Hospital
state: Shanxi
city: Hanzhong
country: China
facility: Hanzhong Central Hospital
state: Shanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People'S Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xianyang
country: China
facility: Xianyang Central Hospital
state: Shanxi
city: Chendu
country: China
facility: The Peoplep'S Hospital of Wenjiang District,Chengdu
state: Sichuan
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Chengdu
country: China
facility: Chengdu First People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Second People'S Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Third People's Hospital
state: Sichuan
city: Guang'an
country: China
facility: West China-Guang'An Hospital,Sichuan University
state: Sichuan
city: Leshan
country: China
facility: The People's Hospital Of Leshan
state: Sichuan
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Sichuan
city: Nanchong
country: China
facility: Nanchong Central Hospital
state: Sichuan
city: Panzhihua
country: China
facility: Panzhihua Central Hospital
state: Sichuan
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
city: Shihezi
country: China
facility: First Affiliated Hospital,School of Medical,Shihezi University
state: Xinjiang
city: Urumqi
country: China
facility: Urumqi Friendship Hospital
state: Xinjiang
city: Dali
country: China
facility: Dali Bai Autonomous Prefecture People'S Hospital
state: Yunnan
Study officials:
affiliation: Shengjing Hospital of China Medical Univeristy
name: Weidong Ren
role: PRINCIPAL_INVESTIGATOR
References: