Cardiac Function
Conditions
Keywords
Ultrasound, Heart, Cardiac function
Brief summary
The goal of this clinical trial is to investigate the influence of ultrasound on cardiac functrion. The main question it aims to answer is: How will ultrasound affect the cardiac function? Researchers will： Apply ultrasound to the body and observe cardiac functions. Participants will: Receive ultrasound application and physiological signal monitoring.
Detailed description
All procedures conducted in this trial comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. All procedures were approved by the Research Ethics Committee of ShanghaiTech University (Q2024-004). The primary outcome is heart rhythm. It will be measured by electrocardiogram. The secondary primary outcome is the incidence of treatment-related adverse events. It will be measured by electrocardiogram and observation.
Interventions
Apply ultrasound to the participant within a safe range.
OTHERNo ultrasound application
No ultrasound application to the participant.
Sponsors
ShanghaiTech University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcomes assessors are blinded to the experimental condition.
Intervention model description
Each participant is randomly assigned to receive either ultrasound intervention at varying intensities or sham control.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy individuals without significant diseases or chronic conditions. * Aged between 18 and 65 years. * Voluntary participation with signed informed consent. * No history of cardiovascular disease.
Exclusion criteria
* Individuals with heart disease or other conditions that may affect cardiac function measurement. * Individuals with implanted electronic devices such as pacemakers or defibrillators. * Those on medications that significantly alter heart rate, such as beta-blockers, unless under stable control for a specific period. * Individuals at risk of severe complications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rhythm. | Throughout the intervention, an average of 1 hour. | 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. |
| Incidence of treatment-related adverse events. | Baseline, during the intervention (an average of 1 hour) and immediately after the intervention (same day, approximately 1 hour after baseline). | 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). |
Countries
China
Contacts
Primary ContactBingbing Cheng, Ph.D.
Outcome results
None listed