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

• Conditions: Healthy Volunteers; Left Ventricular Systolic Dysfunction

• 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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-09
• Study First Submitted QC: 2020-05-19
• Last Update Submitted: 2020-05-19
• Study First Posted: 2020-05-22
• Last Update Posted: 2020-05-22
• Study Start: 2020-06
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
left ventricular systolic function was measured by the two-plane Simpson method	1 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

Gansu Baiyin Second People's Hospital; 🇨🇳 Baiyin, Gansu, China

The First People's Hospital of Foshan City; 🇨🇳 Foshan, Guangdong, China

The People's Hospital of Gaozhou; 🇨🇳 Gaozhou, Guangdong, China

the Second Affiliated Hospital of Guangzhou University of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Qingyuan People's Hospital; 🇨🇳 Qingyuan, Guangdong, China

Affiliated Hospital of YouJiang Medical University for Nationalities; 🇨🇳 Baise, Guangxi, China

People'S Hospital of Baise; 🇨🇳 Baise, Guangxi, China

The People'S Hospital of Chong Zuo; 🇨🇳 Chongzuo, Guangxi, China

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