Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention

ShanghaiTech University6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cardiac Function

Interventions

Ultrasound applicationOTHER

Apply ultrasound to the participant within a safe range.

No ultrasound applicationOTHER

No ultrasound application to the participant.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Bingbing Cheng

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: Baseline, during the intervention (an average of 1 hour) and immediately after the intervention (same day, approximately 1 hour after baseline).

Central Contacts

Bingbing Cheng, Ph.D.

CONTACT

+8620685173 chengbb@shanghaitech.edu.cn

Data from ClinicalTrials.gov

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