Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention
Phase: NA
Conditions: Cardiac Function
Sponsor: ShanghaiTech University

Official title: Investigation of cardiac function with ultrasound  
NCT number: NCT06567106 
Date: October 10, 2024 
 
 

1. Background 
Cardiovascular disease is one of the most common diseases worldwide and one of the leading 
causes of death. Common cardiovascular diseases include coronary artery disease, heart failure, 
and arrhythmias, etc. These diseases affect the structure and function of the heart, leading to 
issues with contraction and relaxation, blood supply, and oxygen transport. Therefore, the 
diagnosis and management of cardiovascular disease are particularly important. Recent 
advancements in medical technology have introduced ultrasound intervention as a promising 
new method for managing cardiovascular diseases, offering an innovative alternative to 
traditional interventions. Ultrasound intervention has the potential to affect the cardiac function. 
By integrating this technology into clinical practice, this technique can provide more 
personalized and effective management options for patients with various cardiovascular 
conditions, ultimately aiming to improve quality of life. 
 
2. Study aims 
The aim of this study is to investigate the cardiac function with ultrasound. We will investigate 
how ultrasound interventions affect cardiac function. This study will contribute to early 
diagnosis, monitoring, and treatment strategies for cardiovascular diseases. 
 
3. Study plan 
Have the participant lie flat and relaxed, maintaining a still position. Prepare the ECG 
equipment and attach the electrodes to the subject's body to record the heart's electrical signals. 
Collect the ECG signal before, during and after ultrasound intervention. Prepare the ultrasound 
equipment and place the ultrasound transducer on the participant's chest, adjusting the angle 
and position as needed. Set the ultrasound parameters and begin the cardiac ultrasound 
experiments. Conduct the experiments and analyze the data. 
 
4. Statistical analysis plan 
4.1 Outcome variables 
4.1.1 Primary outcome 
Variable: Heart rhythm. 
Description: Monitor participants’ electrocardiogram before, during and after ultrasound 
application. Calculate heart rate from the electrocardiogram signal. The change of heart rate is 
calculated as the rate of change relative to the baseline heart rate. Aggregate the data and do 
statistical analysis. Data will be presented as mean with standard deviations. 
Measurement: Electrocardiogram. 
4.1.2 
Secondary primary outcome 
Variable: Incidence of treatment-related adverse events. 
Description: The incidence of treatment-related adverse events includes both minor (such as 
localized discomfort, transient arrhythmias, mild chest pain, short-term dizziness, nausea, and 

temporary shortness of breath) and severe adverse events (including sustained arrhythmias, 
new-onset heart failure, significant myocardial injury, embolic events, or death). 
Measurement: Electrocardiogram and observation. 
4.2 Statistical methodology 
To evaluate the influence of ultrasound intervention on cardiac function, analyze whether 
ultrasound intervention leads to significant differences in cardiac function. Participants will be 
randomly assigned to receive either ultrasound application or the control treatment. The 
differences between the two groups will be analyzed through statistical analysis. Use Shapiro-
Wilk test to determine Gaussian distribution. For normally distributed data, use one-way 
ANOVA followed by Bonferroni multiple comparison tests to analyze the influence of 
ultrasound intervention.  
 
5. Informed consent form 
Title: Investigation of cardiac function with ultrasound 
Principal investigator: Prof. Bingbing Cheng 
You are invited to participate in a clinical study about the investigation of cardiac function with 
ultrasound. This informed consent form provides you with some information to help you decide 
whether to participate in this clinical study. Please read it carefully, and if you have any 
questions, please ask the researcher in charge of the study. 
Your participation in this study is voluntary. This study has been reviewed and approved by the 
Research Ethics Committee of ShanghaiTech University. 
The aim is to investigate the cardiac function with ultrasound, such as heart rate. Arrhythmias 
may affect cardiac systole and diastole, thus impacting the ejection fraction and shortening 
fraction. When the heart contracts in an uncoordinated manner or too rapidly, the ejection 
fraction may decrease because the left ventricle does not have enough time to expel the blood. 
Additionally, cardiac conditions such as myocardial infarction may also lead to decreased 
ejection fraction and shortening fraction. Therefore, these indicators of cardiac function are 
crucial for the diagnosis and management of cardiovascular diseases. 
All equipment used is regularly maintained and inspected to ensure optimal working conditions. 
Before and after the experiment, we will thoroughly clean and disinfect the experimental 
environment. Throughout the experiment, professional personnel will monitor the process to 
promptly respond to any unexpected situations. 
If you agree to participate in this study, we will communicate with you or your family in detail 
and introduce the study's relevant information. We will assign a number to each participant and 
establish a file.  
The ultrasound application part of this study is expected to take no more than 120 minutes in 
total. This includes all necessary preparations, the duration of ultrasound application, and 
recovery time after the ultrasound intervention. 
The experimental parameters used in this study are very safe. A small amount of gel will be 
applied to the skin over the heart, which may cause some discomfort for some individuals. All 
your information will be kept confidential. 
We fully respect and protect the privacy rights of participants. All collected personal 

information and experimental data will be kept strictly confidential and used only for the 
purposes of this study. Under no circumstances will we disclose participants' personal 
information to third parties without explicit consent from the participant. In the publication of 
experimental reports and papers, all participant information will be presented anonymously, 
ensuring that it cannot be traced back to individual identities. 
Participants will receive free ECG and ultrasound application and will receive all examination 
results. Your participation will contribute valuable information to the research of cardiovascular 
diseases. Each participant will receive a fine souvenir. 
As a research participant, you have the following responsibilities: to provide truthful 
information about your medical history and current physical condition; to inform the 
researchers of any discomfort experienced during the study; to avoid taking restricted 
medications, foods, etc.; and to inform the researchers if you have recently participated in other 
studies or are currently participating in other studies. 
If you decide to participate in this study, your participation and personal data in the trial will be 
kept confidential. This information may include your name, address, phone number, medical 
history, and information obtained during your study visits. Identifiable information will not be 
disclosed to members outside the research team without your permission. All research members 
and sponsors are required to keep your identity confidential. When the results of this study are 
published, no personal information about you will be disclosed. 
You may choose not to participate in this study or notify the researchers at any time to withdraw 
from the study. Your data will not be included in the study results, and you will not be 
discriminated against or treated unfairly.