AzTrials
AzTrials

PregnancyNCT05375123

Reference Range for Tissue Motion Tracking of Mitral Annulus Displacement in Chinese Han Singleton Pregnancies

An observational study of Pregnancy, run by First Hospital of China Medical University at 33 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The First Affiliated Hospital of China Medical University initiated a multi-center study on the reference range of tissue motion tracking of mitral annulus displacement in Chinese Han singleton pregnancies to determine the reference range of tissue motion annular displacement (TMAD) in the pregnant population and to… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Pregnancy
What is being tested?
Ultrasound image acquisition
Type of treatment
Medical device
How many people
660 participants
Where
33 sitesChina
Study dates
1 Jul 2022to 30 Jun 2024
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 45 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: A total of 660 singleton pregnant women in the first trimester, who had normal results in various examinations and experienced regular obstetric examinations throughout the pregnancy, were selected from the obstetric outpatients in 33 centers, with 20 cases in each center.

Who may be able to join

  • Singleton pregnancy;
  • Han nationality;
  • 18-45 years old;
  • Basal body mass index before pregnancy < 30 kg/m2;
  • Normal blood pressure (139-90/89-60 mmHg);
  • No history of cardiovascular and respiratory diseases;
Show all 10Show fewer
  • No abnormal findings in the physical examination of the cardiovascular and respiratory systems;
  • Normal results in blood, urine, fasting blood glucose, blood lipids, liver and kidney function, thyroid function and electrocardiogram;
  • Echocardiography shows normal cardiac function with no structural heart diseases;
  • No use of medications that affect the cardiovascular system.

Who cannot join

  • Multiple pregnancy;
  • Anemia (hemoglobin < 90 g/L);
  • Other serious diseases of the immune, respiratory, digestive, nervous, urinary, blood, endocrine and other systems;
  • Tumors;
  • The poor quality of ultrasound images cannot meet the requirements of parameter measurement and analysis.

Trial locations and contacts

33 sites in 1 country.

Chunyan Ma, MD contact

+86 13998816448

mcy_echo@163.com

33 sites in 1 country

China33 sites, 33 recruiting
  • Jilin Provincial Women and Children Health Hospital

    Changchun, Jilin, 130012

    Lili Zhang, MD, +86 13756150838, 602826349@qq.com

    Recruiting
  • Chongqing Fifth People's Hospital

    Chongqing, Chongqing Municipality, 400000

    Zhiwei He, Master, +86 13983408047, 403016330@qq.com

    Recruiting
  • Chongqing Banan District People's Hospital

    Chongqing, Chongqing Municipality, 401320

    Lili Hong, Master, +86 13996201786, 451951415@qq.com

    Recruiting
  • Chongqing Qianjiang District Central Hospital

    Chongqing, Chongqing Municipality, 409000

    Wei Guo, Master, +86 13996909666, 406548331@qq.com

    Recruiting
  • Dalian Friendship Hospital

    Dalian, Liaoning, 116001

    Bo Zhang, MD, +86 15840694167, zb781031dl@hotmail.com

    Recruiting
  • Dalian Municipal Women and Children's Medical Center

    Dalian, Liaoning, 116033

    Yan Liu, PhD, +86 13354072780, wenfengcmu@yeah.net

    Recruiting
  • Maternity and Child Care Centers of Fujian Province

    Fuzhou, Fujian, 350001

    Min Liu, MD, +86 13003816669, liumin6669@163.com

    Recruiting
  • Hainan Women and Children's Medical Center

    Haikou, Hainan, 570312

    Shibin Lin, MD, +86 13976736929, 14393799@qq.com

    Recruiting
  • Heze Municipal Hospital

    Heze, Shandong, 274000

    Huili Fan, MD, +86 19953030992, wydfhl@163.com

    Recruiting
  • Jiamusi Central Hospital

    Jiamusi, Heilongjiang, 154002

    Xin Yang, PhD, +86 15331879588, 1305987946@qq.com

    Recruiting
  • Jilin People's Hospital

    Jilin City, Jilin, 132001

    Xianzhi Wang, Master, +86 18104423461, 1069302604@qq.com

    Recruiting
  • Jilin Central General Hospital

    Jilin City, Jilin, 132011

    Bing Gong, MD, +86 15543430477, 767384287@qq.com

    Recruiting
  • Shandong Maternal and Child Health Hospital

    Jinan, Shandong, 250014

    Hong Yin, MD, +86 18053153367, 18053153367@163.com

    Recruiting
  • Women And Children's Hospital of Jinzhou

    Jinzhou, Liaoning, 121000

    Xuezhu Shao, Master, +86 18904169688, jzsxz6088@163.com

    Recruiting
  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121001

    Yuhong Li, PhD, +86 13940637604, yuhong_jiahui@163.com

    Recruiting
  • Yunnan Maternal And Child Health Care Hospital

    Kunming, Yunnan, 650051

    Lixian Yang, Master, +86 15687890698, 34512088@qq.com

    Recruiting
  • Nanyang First People's Hospital

    Nanyang, Henan, 473000

    Feng Zhou, MD

    Recruiting
  • Panzhihua Maternal and Child Hospital

    Panzhihua, Sichuan, 623000

    Junling Shen, MD, +86 18982303299, 544193695@qq.com

    Recruiting
  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Weidong Ren, PhD, +86 18940251657, renwd01@163.com

    Recruiting
  • Shenyang Maternity And Child Health Hospital

    Shenyang, Liaoning, 110000

    Yunping Guan, MD, +86 18512431616, fygyp2008@sina.com

    Jinmei Gao, MD, +86 13555858947, gjmcy@163.com

    Recruiting
  • the First Hospital of China Medical Univeristy

    Shenyang, Liaoning, 110000

    Chunyan Ma, MD, +8613998816448, mcy_echo@163.com

    Chunyan Ma, MD

    Recruiting
  • Siping Women and Infants Hospital

    Siping, Jilin, 136000

    Wei Li, Master, +86 18504340022, spfylw@163.com

    Recruiting
  • Tieling Women's And Children's Hospital

    Tieling, Liaoning, 112000

    Shuang Xu, Master, +86 13464190066, xushuang@163.com

    Recruiting
  • Weifang Maternal and Child Health Hospital

    Weifang, Shandong, 261011

    Chunxia Wang, MD, +86 13793655998, 13793655998@163.com

    Recruiting
  • The Center Hospital of Wuhan

    Wuhan, Hubei, 430014

    Jianxin Liu, PhD, +86 13647237661, aljxuv@sina.com

    Recruiting
  • Maternal and Child Health Care Hospital Hubei

    Wuhan, Hubei, 430070

    Sheng Zhao, PhD, +86 13667190934, 1015568495@qq.com

    Recruiting
  • ShaanXi Province People's Hospital

    Xi'an, Shaanxi, 710068

    Xiangping Guan, Master, +86 13991979638, 13991979638@139.com

    Recruiting
  • Qinghai Provincial Maternal and Child Health Hospital

    Xining, Qinghai, 810000

    Yingfang Wa, Master, +86 13897262492, qh2556@163.com

    Recruiting
  • Yaan People's Hospital

    Ya'an, Sichuan, 625000

    Dan Tian, Master, +86 18908160262, 806984930@qq.com

    Recruiting
  • Yanji Maternal and Infant Hospital

    Yanji, Jilin, 133001

    Yingchun Cui, Master, +86 13704436465, 1619565837@qq.com

    Recruiting
  • Ningxia Maternal And Child Health Care Hospital

    Yinchuan, Ningxia, 750000

    Xueqin Ji, MD, +86 13995317304, jinian54@163.com

    Recruiting
  • The Third Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Hezhou Li, PhD, +86 13838550002, lihezhou67@126.com

    Recruiting
  • ZiBo Central Hospital

    Zibo, Shandong, 255020

    Xiaoguang Huo, MD, +86 18653399919, 18653399919@163.cm

    Recruiting

Other trials in China

About this study

Official title: Reference Range for Tissue Motion Tracking of Mitral Annulus Displacement in Chinese Han Singleton Pregnancies: a Prospective, Multicenter, Clinical Trial

The First Affiliated Hospital of China Medical University initiated a multi-center study on the reference range of tissue motion tracking of mitral annulus displacement in Chinese Han singleton pregnancies to determine the reference range of tissue motion annular displacement (TMAD) in the pregnant population and to promote the clinical application of TMAD in the pregnant population, thereby offering new insights into the early evaluation and early diagnosis for cardiac function in the pregnant population.

Read the detailed description

During normal pregnancy, the cardiovascular system of pregnant women will undergo significant adaptive changes in response to the growth of the uterus, fetus and placenta. Cardiac output and plasma volume will increase by 40% to 50% compared with non-pregnancy. The heart rate continues to increase, while the blood pressure decreases in the first and second trimesters and increases in the third trimester. The heart structure of pregnant women also remodels during pregnancy and the inner diameter of the cardiac cavity and myocardial mass increase. The above changes usually return to pre-pregnancy levels within 3-6 months after delivery. Pregnancy can change hemodynamics and cardiac structure, thereby causing corresponding changes in maternal cardiac function. Adaptive changes in maternal cardiac function can be reflected through an accurate and rapid evaluation. Changes in maternal cardiac function can be continuously observed and analyzed during pregnancy and after delivery to uncover the changing law of maternal cardiac function.

In addition, the incidence of cardiovascular disease in pregnancy is 1-4% worldwide, and about 15% of maternal deaths are caused by complications related to cardiovascular diseases during pregnancy. In China, the proportion of maternal deaths caused by cardiovascular diseases during pregnancy is increasing yearly and cardiovascular diseases during pregnancy have become the primary cause of death for critically ill pregnant women. Previous studies have shown that common complications during pregnancy, such as gestational hypertension and diabetes, can also alter maternal heart function. Therefore, early detection of changes in left ventricular systolic function of pregnant women during pregnancy and after childbirth, timely treatment and early evaluation of treatment efficacy can greatly reduce their mortality.

The Simpson's biplane method is currently used to measure left ventricular ejection fraction for clinical evaluation of left ventricular systolic function, which is especially available for patients without left ventricular geometric deformation. However, left ventricular ejection fraction cannot be sensitive to early changes in cardiac function. In recent years, two-dimensional longitudinal strain has been included for evaluating left ventricular systolic function. Myocardial longitudinal motion is responsible for maintaining 70% of normal cardiac function. Researchers believe that this method can sensitively detect early changes in left ventricular systolic function. However, the above two methods have high requirements on the quality of ultrasound images, which can clearly display the endocardium and epicardium based on good sound-transmitting conditions and good image quality. However, the image quality of pregnant women is often poor, so there is a decline in the detection accuracy.

Previous studies have shown that TMAD is independent of image quality and can effectively evaluate left ventricular systolic function and is an effective supplement to left ventricular ejection fraction and the overall longitudinal strain of the left ventricle. TMAD is a new technique for quantitative analysis of mitral annulus motion parameters. Three observation points are set on the septal side, lateral side and apex of the mitral annulus in the apical four-chamber view. The movement of the mitral annulus relative to the apex will be detected to obtain the lateral displacement of the mitral annulus septum (TMAD sep), the lateral displacement of the mitral annulus (TMAD lat), the mean displacement (TMADmid), and the mean displacement rate (TMADmidpt%). The left ventricular longitudinal systolic function will be then evaluated. TMAD only requires image acquisition from three sites and has low requirements on the quality of ultrasound images. Therefore, this measurement is simple, accurate and highly repeatable.

However, the TMAD reference value of normal healthy adults cannot be directly applied to pregnant women due to the hemodynamic changes during pregnancy. It is still necessary to establish the reference value of TMAD in pregnant women and explore its changes with gestational age, so as to provide simple, fast, accurate ultrasound parameters that do not depend on image quality for the evaluation of cardiac function during pregnancy.

The purpose of this study is to establish the reference range of TMAD parameters in Chinese Han singleton pregnancies in different pregnancy periods and early postpartum period and to explore the influencing factors of TMAD in singleton pregnancies.

Conditions
Pregnancy
Being tested
Ultrasound image acquisition
Keywords
Pregnancy, Left Ventricular Systolic Function, Tissue Motion Tracking of Mitral Annular Displacement

What participants receive

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

  • Ultrasound image acquisitionDevice

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

    Time points for heart image acquisition in pregnant women: As per the Guidelines for Pre-pregnancy and Pregnancy Health Care (2018) formulated by the Obstetrics Group of the Gynecology Branch of the Chinese Medical Association, a total of six echocardiographic examinations will be performed in the first trimester (11-14 weeks of gestation), the second trimester (20-24 weeks of gestation), the third trimester (29-32 weeks of gestation), prenatal term (37-41 weeks of gestation), 6 weeks and 3-6 months after delivery.

    Time points for fetal heart image acquisition: Fetal heart images will be collected in the second trimester (20 to 24 weeks of gestation).

Study groups in NCT05375123
Study groupRoleWhat they receive
Trial groupA total of 660 singleton pregnant women in the first trimester (gestational age of 6-13 weeks + 6 days), who had normal results in various examinations and experienced regular obstetric examinations throughout the pregnancy, were selected from the obstetric outpatients in 33 centers, with 20 cases in each center.
Receives: Device: Ultrasound image acquisition

What is being measured

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

  1. Measurement of left ventricular systolic function in Chinese Han singleton pregnancies using the TMAD method

    To establish the reference range of TMADmid and TMADmidpt% in Chinese Han singleton pregnancies using the TMAD method.

    Measured: From 11 weeks of gestation to 3-6 months postpartum

Secondary outcomes (1)
  1. Measurement of left ventricular systolic function using the Simpson's biplane method

    Measurement of left ventricular ejection fraction measured by the Simpson's biplane method is a clinical standard

    Measured: From 11 weeks of gestation to 3-6 months postpartum

Timeline

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

  1. First posted16 May 2022
  2. Study start1 Jul 2022
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Jun 2024 (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
Cohort
Time perspective
Prospective
Enrolment
660 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05375123
Sponsor's protocol ID
REVAW-TMAD-01
Status last verified
Jul 2022
First submitted
29 Apr 2022
Last updated
15 Jul 2022
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 Pregnancy, run by First Hospital of China Medical University at 33 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 10 inclusion and 5 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 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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 Chunyan Ma, MD (+86 13998816448, mcy_echo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of left ventricular systolic function in Chinese Han singleton pregnancies using the TMAD method (time frame: From 11 weeks of gestation to 3-6 months postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Jul 2022.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT05375123 | AzTrials