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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound application at minimal intensity | Experimental | Apply minimal-intensity ultrasound to the participant. The intensity is below 2 W/cm². |
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| Ultrasound application at mild intensity | Experimental | Apply mild-intensity ultrasound to the participant. The intensity is below 3 W/cm². |
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| Ultrasound application at medium intensity | Sham Comparator | Apply medium-intensity ultrasound to the participant. The intensity is below 5 W/cm². |
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| No ultrasound application | Sham Comparator | No ultrasound application to the participant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound application | Other | Apply ultrasound to the participant within a safe range. |
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| Measure | Description | Time Frame |
|---|---|---|
| Heart rhythm. | 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. | Throughout the intervention, an average of 1 hour. |
| Incidence of treatment-related adverse events. | 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). | Baseline, during the intervention (an average of 1 hour) and immediately after the intervention (same day, approximately 1 hour after baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bingbing Cheng, Ph.D. | Contact | +8620685173 | chengbb@shanghaitech.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bingbing Cheng | Recruiting | Shanghai | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 10, 2024 | Oct 11, 2024 | Prot_SAP_ICF_001.pdf |
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Each participant is randomly assigned to receive either ultrasound intervention at varying intensities or sham control.
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Participants and outcomes assessors are blinded to the experimental condition.
| No ultrasound application | Other | No ultrasound application to the participant. |
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