Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Heart rhythm.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcomes assessors are blinded to the experimental condition.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Heart rhythm.
时间窗: 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.
时间窗: 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).
次要结局
未报告次要终点
研究者
Bingbing Cheng
Assistant Professor
ShanghaiTech University