NCT04399447

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

76 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

May 9, 2020

Last Update Submit

May 19, 2020

Conditions

Keywords

systolic functionleft ventricularnormal

Outcome Measures

Primary Outcomes (2)

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

    To establish the range of TMADmid by using TMAD

    1 day

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

    To establish the range of TMADmidpt% by using TMAD

    1 day

Secondary Outcomes (1)

  • left ventricular systolic function was measured by the two-plane Simpson method

    1 day

Other Outcomes (1)

  • Serum biochemical index

    1 day

Study Arms (6)

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

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

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

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

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

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

Interventions

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

18-29 year-old group30-39 year-old group40-49 year-old group50-59 year-old group60-69 year-old group70-79 year-old group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (76)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Gansu Baiyin Second People's Hospital

Baiyin, Gansu, China

RECRUITING

The First People's Hospital of Foshan City

Foshan, Guangdong, China

RECRUITING

The People's Hospital of Gaozhou

Gaozhou, Guangdong, China

RECRUITING

the Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

RECRUITING

Qingyuan People's Hospital

Qingyuan, Guangdong, China

RECRUITING

Affiliated Hospital of YouJiang Medical University for Nationalities

Baise City, Guangxi, China

RECRUITING

People'S Hospital of Baise

Baise City, Guangxi, China

RECRUITING

The People'S Hospital of Chong Zuo

Chongzuo, Guangxi, China

RECRUITING

Guigang City People'S Hospital

Guigang, Guangxi, China

RECRUITING

Laibin People's Hospital

Laibin, Guangxi, China

RECRUITING

Guangxi International Zhuang Medical Hospital

Nanning, Guangxi, China

RECRUITING

Guangxi Minzu Hospital

Nanning, Guangxi, China

RECRUITING

The first peopel's hospital of yulin

Yulin, Guangxi, China

RECRUITING

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

RECRUITING

Nanyang Second People's Hospital

Nanyang, He'nan, China

RECRUITING

Fengning Manchu Autonomous County Hospital

Chengde, Hebei, China

RECRUITING

Handan First Hospital

Handan, Hebei, China

RECRUITING

shijiazhuang No.1 Hospital

Shijiazhuang, Hebei, China

RECRUITING

The Fourth Hospital of Heibei Medical University Hebei Cancer Hospital

Shijiazhuang, Hebei, China

RECRUITING

Tangshan fengnan district hospital

Tangshan, Hebei, China

RECRUITING

Xingtai Third Hospital

Xingtai, Hebei, China

RECRUITING

Mudanjiang Cardiovascular Hospital

Mudanjiang, Heilongjiang, China

RECRUITING

The Third Affiliated Hospital of Qiqihar Medical Hospital

Qiqihar, Heilongjiang, China

RECRUITING

People'S Hospital of Hunan Province

Changsha, Hunan, China

RECRUITING

The First People's Hospital of Huaihua

Huaihua, Hunan, China

RECRUITING

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China

RECRUITING

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

RECRUITING

Jiujiang University Affiliated Hospital

Jiujiang, Jiangxi, China

RECRUITING

Baicheng Central Hospital

Baicheng, Jilin, China

RECRUITING

Jilin Central General Hospital

Jilin, Jilin, China

RECRUITING

Benxi Central Hospital

Benxi, Liaoning, China

RECRUITING

Chaoyang Central Hospital

Chaoyang, Liaoning, China

RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

RECRUITING

Dalian Municipal Central Hospital

Dalian, Liaoning, 116033, China

RECRUITING

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

RECRUITING

DanDong central hospital

Dandong, Liaoning, China

RECRUITING

Fuchun Central Hospital

Fushun, Liaoning, China

RECRUITING

General Hospital of Fushun Mining Bureau

Fushun, Liaoning, China

RECRUITING

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Central Hospital Affiliated To ShenYang Medical College

Shenyang, Liaoning, China

RECRUITING

The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

The People'S Hospital of Liaoning Province

Shenyang, Liaoning, China

RECRUITING

the Second Affiliated Hospital Of Shenyang Medical College

Shenyang, Liaoning, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

RECRUITING

Qinghai Provincial People's Hospital

Xining, Qinghai, China

RECRUITING

The Second Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Liaocheng People'S Hospital

Liaocheng, Shandong, China

RECRUITING

Yantai Affiliated Hospital of Binzhou Medical University

Yantai, Shandong, China

RECRUITING

Zibo City Linzi District People's Hospital

Zibo, Shandong, China

RECRUITING

Shanghai Pudong New District Zhoupu Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Baoji Central Hospital

Baoji, Shanxi, China

RECRUITING

Hanzhong Central Hospital

Hanzhong, Shanxi, China

RECRUITING

Xianyang Central Hospital

Xianyang, Shanxi, China

RECRUITING

Shaanxi Provincial People'S Hospital

Xi’an, Shanxi, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

RECRUITING

Chengdu First People's Hospital

Chengdu, Sichuan, China

RECRUITING

Chengdu Second People'S Hospital

Chengdu, Sichuan, China

RECRUITING

Chengdu Third People's Hospital

Chengdu, Sichuan, China

RECRUITING

The Peoplep'S Hospital of Wenjiang District,Chengdu

Chengdu, Sichuan, China

RECRUITING

West China-Guang'An Hospital,Sichuan University

Guang’an, Sichuan, China

RECRUITING

The People's Hospital Of Leshan

Leshan, Sichuan, China

RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

RECRUITING

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

RECRUITING

Nanchong Central Hospital

Nanchong, Sichuan, China

RECRUITING

Panzhihua Central Hospital

Panzhihua, Sichuan, China

RECRUITING

Suining Central Hospital

Suining, Sichuan, China

RECRUITING

First Affiliated Hospital,School of Medical,Shihezi University

Shihezi, Xinjiang, China

RECRUITING

Urumqi Friendship Hospital

Ürümqi, Xinjiang, China

RECRUITING

Dali Bai Autonomous Prefecture People'S Hospital

Dali, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • Weidong Ren

    Shengjing Hospital of China Medical Univeristy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of Ultrasound

Study Record Dates

First Submitted

May 9, 2020

First Posted

May 22, 2020

Study Start

June 1, 2020

Primary Completion

June 30, 2021

Study Completion

September 30, 2021

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations