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Left Ventricular Systolic DysfunctionTMADNCT04399447

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

An observational study of Left Ventricular Systolic Dysfunction and Healthy Volunteers, run by Weidong Ren at 76 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
What is being tested?
Echocardiography
Type of treatment
Surgery or procedure
How many people
2,400 participants
Where
76 sitesChina
Study dates
Jun 2020to 30 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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).

Who may be able to join

  • Han nationality
  • Ages 18-79.
  • Normal body mass index (18-25kg / m2).
  • Normal blood pressure (139-90 / 89-60mmHg).
  • No history of cardiovascular and respiratory diseases.
  • No abnormality was found in physical examination of cardiovascular and respiratory system.
Show all 9Show fewer
  • Blood glucose, lipid profile and electrocardiogram were normal.
  • Echocardiography showed no structural heart disease and normal heart function.
  • No history of medications affecting cardiovascular system.

Who cannot join

  • Clinically significant or moderate heart valve regurgitation.
  • Respiratory diseases: acute or chronic respiratory diseases.
  • Endocrine diseases: thyroid disease, diabetes, hyperaldosteronism, pheochromocytoma, and abnormal adrenal function.
  • Anemia.
  • Pregnant or lactating women.
  • 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).
Show all 12Show fewer
  • Connective tissue disease.
  • Tumor.
  • Aortic and peripheral vascular diseases: aortic dilatation, aortic dissection, aortic constriction, multiple arteritis, and atherosclerosis.
  • Drink more than 50ml of white wine daily; more than 100ml of red wine; more than 300ml of beer.
  • Professional athletes.
  • The poor quality of the ultrasound image cannot satisfy the parameter measurement and analysis.

Trial locations and contacts

76 sites in 1 country.

Weidong Ren contact

8618940251657

renwd01@163.com

76 sites in 1 country

China76 sites, 76 recruiting

  • Baicheng Central Hospital

    Baicheng, Jilin

    Fan Zhang, 13943623116

    Fan Zhang

    Recruiting

  • Affiliated Hospital of YouJiang Medical University for Nationalities

    Baise City, Guangxi

    Chengcai Chen, 13977617591

    Chengcai Chen

    Recruiting

  • People'S Hospital of Baise

    Baise City, Guangxi

    Maoyi Li, 18677628852

    Maoyi Li

    Recruiting

  • Gansu Baiyin Second People's Hospital

    Baiyin, Gansu

    Xinjian Yang, 13619308289

    Xinjian Yang

    Recruiting

  • Baoji Central Hospital

    Baoji, Shanxi

    Guoliang Dun, 13509176168

    Guoliang Dun

    Recruiting

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia

    Guozhen Yan, 18547218068

    Guozhen Yan

    Recruiting

  • Benxi Central Hospital

    Benxi, Liaoning

    Xingbin Wang, 18941435757

    Xingbin Wang

    Recruiting

  • People'S Hospital of Hunan Province

    Changsha, Hunan

    Kun Ao, 13467511183

    Kun Ao

    Recruiting

  • Chaoyang Central Hospital

    Chaoyang, Liaoning

    Suli Zhang, 18040159891

    Suli Zhang

    Recruiting

  • Fengning Manchu Autonomous County Hospital

    Chengde, Hebei

    Dongsheng Zhao, 13483872058

    Dongsheng Zhao

    Recruiting

  • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan

    Yu Kang

    Yu Kang

    Recruiting

  • Chengdu First People's Hospital

    Chengdu, Sichuan

    Xinyun Chen, 18011390127

    Xinyun Chen

    Recruiting

  • Chengdu Second People'S Hospital

    Chengdu, Sichuan

    Yun Shi, 13658051337

    Yun Shi

    Recruiting

  • Chengdu Third People's Hospital

    Chengdu, Sichuan

    Feng Xiong

    Feng Xiong

    Recruiting

  • The Peoplep'S Hospital of Wenjiang District,Chengdu

    Chengdu, Sichuan

    Jing Tan, 13708204839

    Jing Tan

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

    Fang Li, 13808312288

    Fang Li

    Recruiting

  • The People'S Hospital of Chong Zuo

    Chongzuo, Guangxi

    Mei Li, 13807873360

    Mei Li

    Recruiting

  • Dali Bai Autonomous Prefecture People'S Hospital

    Dali, Yunnan

    Yan Cui, 13987275528

    Yan Cui

    Recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

    Tao Cong, 18098875836

    Tao Cong

    Recruiting

  • Dalian Municipal Central Hospital

    Dalian, Liaoning, 116033

    Xiaofang Pan, 13591327871

    Xiaofang Pan

    Recruiting

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

    Jun Wu, 13942022794

    Jun Wu

    Recruiting

  • DanDong central hospital

    Dandong, Liaoning

    Xin Jin, 13842580705

    Xin Jin

    Recruiting

  • The First People's Hospital of Foshan City

    Foshan, Guangdong

    Yuqiong Lai, 13809859038

    Yuqiong Lai

    Recruiting

  • Fuchun Central Hospital

    Fushun, Liaoning

    Chen Zhang, 13941314545

    Chen Zhang

    Recruiting

  • General Hospital of Fushun Mining Bureau

    Fushun, Liaoning

    Chunfeng Wang, 15694239647

    Chunfeng Wang

    Recruiting

  • The People's Hospital of Gaozhou

    Gaozhou, Guangdong

    Guoxiong Wei, 13580011299

    Guoxiong Wei

    Recruiting

  • West China-Guang'An Hospital,Sichuan University

    Guang’an, Sichuan

    Shuwen Chen, 13550980666

    Shuwen Chen

    Recruiting

  • the Second Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong

    Pengtao Sun, 18620168536

    Pengtao Sun

    Recruiting

  • Guigang City People'S Hospital

    Guigang, Guangxi

    Zongxin Tao, 13737559953

    Zongxin Tao

    Recruiting

  • The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan

    Ruixia Nan, 13036006449

    Ruixia Nan

    Recruiting

  • Handan First Hospital

    Handan, Hebei

    Shaobo Wang, 15631006699

    Shaobo Wang

    Recruiting

  • Hanzhong Central Hospital

    Hanzhong, Shanxi

    Zipeng Liu, 13084899536

    Zipeng Liu

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui

    Haoyi Yang, 13720360838

    Haoyi Yang

    Recruiting

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

    Xiaoshan Zhang, 13947133133

    Xiaoshan Zhang

    Recruiting

  • The First People's Hospital of Huaihua

    Huaihua, Hunan

    Rui Zhang, 13973099796

    Rui Zhang

    Recruiting

  • Jilin Central General Hospital

    Jilin City, Jilin

    Bing Gong, 15543430477

    Bing Gong

    Recruiting

  • The Second Hospital of Shandong University

    Jinan, Shandong

    Yongmei Wang, 15153169591

    Yongmei Wang

    Recruiting

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning

    Yuhong Li, 13940637604

    Yuhong Li

    Recruiting

  • Jiujiang University Affiliated Hospital

    Jiujiang, Jiangxi

    Xuehua Xiao, 13517920820

    Xuehua Xiao

    Recruiting

  • Laibin People's Hospital

    Laibin, Guangxi

    Xianling Mo, 18907828711

    Xianling Mo

    Recruiting

  • The People's Hospital Of Leshan

    Leshan, Sichuan

    Ying Liu, 17628182552

    Ying Liu

    Recruiting

  • Liaocheng People'S Hospital

    Liaocheng, Shandong

    Yilin Liu, 13346251883

    Yilin Liu

    Recruiting

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan

    Jizhu Xia, 18715770806

    Jizhu Xia

    Recruiting

  • Mudanjiang Cardiovascular Hospital

    Mudanjiang, Heilongjiang

    Guangyu Gao, 13704838773

    Guangyu Gao

    Recruiting

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan

    Wensheng Yue, 13690767960

    Wensheng Yue

    Recruiting

  • Nanchong Central Hospital

    Nanchong, Sichuan

    Xuebin Liu, 15882613551

    Xuebin Liu

    Recruiting

  • Guangxi International Zhuang Medical Hospital

    Nanning, Guangxi

    Minhua Chen, 13517689974

    Minhua Chen

    Recruiting

  • Guangxi Minzu Hospital

    Nanning, Guangxi

    Haiqing Su, 13978827211

    Haiqing Su

    Recruiting

  • Nanyang Second People's Hospital

    Nanyang, He'nan

    Xu meng Ding, 13503779799

    Xu meng Ding

    Recruiting

  • Panzhihua Central Hospital

    Panzhihua, Sichuan

    Xiaoli Wu, 13982323405

    Xiaoli Wu

    Recruiting

  • Qingyuan People's Hospital

    Qingyuan, Guangdong

    Liwen Wu, 13802896000

    Liwen Wu

    Recruiting

  • The Third Affiliated Hospital of Qiqihar Medical Hospital

    Qiqihar, Heilongjiang

    Xiao Liang, 13846283727

    Xiao Liang

    Recruiting

  • Shanghai Pudong New District Zhoupu Hospital

    Shanghai, Shanghai Municipality

    Ye Song, 13818086439

    Ye Song

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Weidong Ren, 18940251657, renwd01@163.com

    Lu Sun

    Recruiting

  • Central Hospital Affiliated To ShenYang Medical College

    Shenyang, Liaoning

    Tong Zang, 18002477367

    Tong Zang

    Recruiting

  • The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning

    Linwei Hong, 18040041999

    Linwei Hong

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning

    Jun Yang, 13840266962

    Jun Yang

    Recruiting

  • The People'S Hospital of Liaoning Province

    Shenyang, Liaoning

    Fang Zhu, 17702485777

    Fang Zhu

    Recruiting

  • the Second Affiliated Hospital Of Shenyang Medical College

    Shenyang, Liaoning

    Jie Liu, 18002452866

    Jie Liu

    Recruiting

  • First Affiliated Hospital,School of Medical,Shihezi University

    Shihezi, Xinjiang

    Guilin Lu, 13899527866

    Guilin Lu

    Recruiting

  • shijiazhuang No.1 Hospital

    Shijiazhuang, Hebei

    Xiaoqing Yang, 17603119685

    Xiaoqing Yang

    Recruiting

  • The Fourth Hospital of Heibei Medical University Hebei Cancer Hospital

    Shijiazhuang, Hebei

    Xiaohong Gong, 13831110712

    Xiaohong Gong

    Recruiting

  • Suining Central Hospital

    Suining, Sichuan

    Xiaoyong Luo, 18008258086

    Xiaoyong Luo

    Recruiting

  • Tangshan fengnan district hospital

    Tangshan, Hebei

    Yihong Li, 19931565611

    Yihong Li

    Recruiting

  • Urumqi Friendship Hospital

    Ürümqi, Xinjiang

    Baoling Wang, 13579235938

    Baoling Wang

    Recruiting

  • Shaanxi Provincial People'S Hospital

    Xi’an, Shanxi

    Xiangping Guan, 13991979638

    Xiangping Guan

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Litao Ruan, 13572815126

    Litao Ruan

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Shun Wang, 18991232635

    Shun Wang

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Qi Zhou, 18966896600

    Qi Zhou

    Recruiting

  • Xianyang Central Hospital

    Xianyang, Shanxi

    Lei Cui, 13809141343

    Lei Cui

    Recruiting

  • Xingtai Third Hospital

    Xingtai, Hebei

    Hongbing Peng, 13131991001

    Hongbing Peng

    Recruiting

  • Qinghai Provincial People's Hospital

    Xining, Qinghai

    Haixia Sun, 18597015698

    Haixia Sun

    Recruiting

  • Yantai Affiliated Hospital of Binzhou Medical University

    Yantai, Shandong

    Jiange Li, 18363805900

    Jiange Li

    Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

    Lisha Na, 13995376025

    Lisha Na

    Recruiting

  • The first peopel's hospital of yulin

    Yulin, Guangxi

    Hongxia Yin, 18977585936

    Hongxia Yin

    Recruiting

  • Zibo City Linzi District People's Hospital

    Zibo, Shandong

    Ying Liu, 17660292589

    Ying Liu

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
Echocardiography
Keywords
systolic function, left ventricular, normal
Medical subject headings
Ventricular Dysfunction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EchocardiographyRadiation

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

Study groups in NCT04399447
Study groupRoleWhat they receive
18-29 year-old groupBased 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.
Receives: Radiation: Echocardiography
30-39 year-old groupBased 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.
Receives: Radiation: Echocardiography
40-49 year-old groupBased 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.
Receives: Radiation: Echocardiography
50-59 year-old groupBased 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.
Receives: Radiation: Echocardiography
60-69 year-old groupBased 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.
Receives: Radiation: Echocardiography
70-79 year-old groupBased 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.
Receives: Radiation: Echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    To establish the range of TMADmid by using TMAD

    Measured: 1 day

  2. left ventricular systolic function was measured by tissue motion tracking of mitral annular displacement（TMAD）

    To establish the range of TMADmidpt% by using TMAD

    Measured: 1 day

Secondary outcomes (1)

  1. 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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study startJun 2020 (estimated)
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion30 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04399447
Sponsor's protocol ID
ShengJing Hospital Ultrasound
Acronym
TMAD
Status last verified
May 2020
First submitted
9 May 2020
Last updated
22 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Left Ventricular Systolic Dysfunction and Healthy Volunteers, run by Weidong Ren at 76 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Weidong Ren (8618940251657, renwd01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

left ventricular systolic function was measured by tissue motion tracking of mitral annular displacement（TMAD） (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04399447.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.

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