Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention

Not Applicable

Recruiting

• Conditions: Cardiac Function
• Interventions: Other: No ultrasound application; Other: Ultrasound application

• Registration Number: NCT06567106
• Lead Sponsor: ShanghaiTech University

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.

Study Timeline

• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-22
• Status Verified: 2024-10
• Study Start: 2024-10-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Primary Completion: 2027-10-10
• Study Completion: 2027-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham	No ultrasound application	No ultrasound application to the participant.
Ultrasound	Ultrasound application	Apply ultrasound to the participant.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Bingbing Cheng; 🇨🇳 Shanghai, China