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

Sponsor
Weidong Ren (Other)
Overall Status
Unknown status
CT.gov ID
NCT04399447
Collaborator
(none)
2,400
76
16
31.6
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Echocardiography

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 Design

Study Type:
Observational
Anticipated Enrollment :
2400 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Multi-center Normal Reference Study of Tissue Motion Tracking of Mitral Annular Displacement(TMAD) in Chinese Han Adults Study
Anticipated Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm 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.

Radiation: Echocardiography
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.

Radiation: Echocardiography
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.

Radiation: Echocardiography
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.

Radiation: Echocardiography
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.

Radiation: Echocardiography
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.

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

Outcome Measures

Primary Outcome Measures

  1. left ventricular systolic function was measured by tissue motion tracking of mitral annular displacement(TMAD) [1 day]

    To establish the range of TMADmid by using TMAD

  2. 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

  1. 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

Other Outcome Measures

  1. Serum biochemical index [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui Provincial Hospital Hefei Anhui China
2 Chongqing University Cancer Hospital Chongqing Chongqing China
3 Gansu Baiyin Second People's Hospital Baiyin Gansu China
4 The First People's Hospital of Foshan City Foshan Guangdong China
5 The People's Hospital of Gaozhou Gaozhou Guangdong China
6 the Second Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou Guangdong China
7 Qingyuan People's Hospital Qingyuan Guangdong China
8 Affiliated Hospital of YouJiang Medical University for Nationalities Baise Guangxi China
9 People'S Hospital of Baise Baise Guangxi China
10 The People'S Hospital of Chong Zuo Chongzuo Guangxi China
11 Guigang City People'S Hospital Guigang Guangxi China
12 Laibin People's Hospital Laibin Guangxi China
13 Guangxi International Zhuang Medical Hospital Nanning Guangxi China
14 Guangxi Minzu Hospital Nanning Guangxi China
15 The first peopel's hospital of yulin Yulin Guangxi China
16 The First Affiliated Hospital of Hainan Medical University Haikou Hainan China
17 Fengning Manchu Autonomous County Hospital Chengde Hebei China
18 Handan First Hospital Handan Hebei China
19 shijiazhuang No.1 Hospital Shijiazhuang Hebei China
20 The Fourth Hospital of Heibei Medical University Hebei Cancer Hospital Shijiazhuang Hebei China
21 Tangshan fengnan district hospital Tangshan Hebei China
22 Xingtai Third Hospital Xingtai Hebei China
23 Mudanjiang Cardiovascular Hospital Mudanjiang Heilongjiang China
24 The Third Affiliated Hospital of Qiqihar Medical Hospital Qiqihar Heilongjiang China
25 Nanyang Second People's Hospital Nanyang Henan China
26 People'S Hospital of Hunan Province Changsha Hunan China
27 The First People's Hospital of Huaihua Huaihua Hunan China
28 The First Affiliated Hospital of Baotou Medical College Baotou Inner Mongolia China
29 The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia China
30 Jiujiang University Affiliated Hospital Jiujiang Jiangxi China
31 Baicheng Central Hospital Baicheng Jilin China
32 Jilin Central General Hospital Jilin Jilin China
33 Benxi Central Hospital Benxi Liaoning China
34 Chaoyang Central Hospital Chaoyang Liaoning China
35 The First Affiliated Hospital of Dalian Medical University Dalian Liaoning China 116011
36 Dalian Municipal Central Hospital Dalian Liaoning China 116033
37 The Second Affiliated Hospital of Dalian Medical University Dalian Liaoning China
38 DanDong central hospital Dandong Liaoning China
39 Fuchun Central Hospital Fushun Liaoning China
40 General Hospital of Fushun Mining Bureau Fushun Liaoning China
41 The First Affiliated Hospital of Jinzhou Medical University Jinzhou Liaoning China
42 Shengjing Hospital of China Medical University Shenyang Liaoning China 110004
43 Central Hospital Affiliated To ShenYang Medical College Shenyang Liaoning China
44 The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang Liaoning China
45 The First Hospital of China Medical University Shenyang Liaoning China
46 The People'S Hospital of Liaoning Province Shenyang Liaoning China
47 the Second Affiliated Hospital Of Shenyang Medical College Shenyang Liaoning China
48 General Hospital of Ningxia Medical University Yinchuan Ningxia China
49 Qinghai Provincial People's Hospital Xining Qinghai China
50 The Second Hospital of Shandong University Jinan Shandong China
51 Liaocheng People'S Hospital Liaocheng Shandong China
52 Yantai Affiliated Hospital of Binzhou Medical University Yantai Shandong China
53 Zibo City Linzi District People's Hospital Zibo Shandong China
54 Shanghai Pudong New District Zhoupu Hospital Shanghai Shanghai China
55 Baoji Central Hospital Baoji Shanxi China
56 Hanzhong Central Hospital Hanzhong Shanxi China
57 Shaanxi Provincial People'S Hospital Xi'an Shanxi China
58 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi China
59 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi China
60 The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi China
61 Xianyang Central Hospital Xianyang Shanxi China
62 The Peoplep'S Hospital of Wenjiang District,Chengdu Chendu Sichuan China
63 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Chengdu Sichuan China
64 Chengdu First People's Hospital Chengdu Sichuan China
65 Chengdu Second People'S Hospital Chengdu Sichuan China
66 Chengdu Third People's Hospital Chengdu Sichuan China
67 West China-Guang'An Hospital,Sichuan University Guang'an Sichuan China
68 The People's Hospital Of Leshan Leshan Sichuan China
69 The Affiliated Hospital of Southwest Medical University Luzhou Sichuan China
70 Affiliated Hospital of North Sichuan Medical College Nanchong Sichuan China
71 Nanchong Central Hospital Nanchong Sichuan China
72 Panzhihua Central Hospital Panzhihua Sichuan China
73 Suining Central Hospital Suining Sichuan China
74 First Affiliated Hospital,School of Medical,Shihezi University Shihezi Xinjiang China
75 Urumqi Friendship Hospital Urumqi Xinjiang China
76 Dali Bai Autonomous Prefecture People'S Hospital Dali Yunnan China

Sponsors and Collaborators

  • Weidong Ren

Investigators

  • Principal Investigator: Weidong Ren, Shengjing Hospital of China Medical Univeristy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weidong Ren, Chief of Ultrasound, Shengjing Hospital
ClinicalTrials.gov Identifier:
NCT04399447
Other Study ID Numbers:
  • ShengJing Hospital Ultrasound
First Posted:
May 22, 2020
Last Update Posted:
May 22, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Weidong Ren, Chief of Ultrasound, Shengjing Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2020