Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05375123 |
| Other study ID # |
REVAW-TMAD-01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2022 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
July 2022 |
| Source |
First Hospital of China Medical University |
| Contact |
Chunyan Ma, MD |
| Phone |
+86 13998816448 |
| Email |
mcy_echo[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
