Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention
ConditionCardiac Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorShanghaiTech University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Ultrasound application
Other interventionApply ultrasound to the participant within a safe range.
No ultrasound application
Other interventionNo ultrasound application to the participant.
Treatment groups
6 Participants
are divided into 4 treatment groupsGroup A: Ultrasound application at minimal intensityExperimental treatment 1 intervention
Group B: Ultrasound application at mild intensityExperimental treatment 1 intervention
Group C: Ultrasound application at medium intensitySham comparator 1 intervention
Group D: No ultrasound applicationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov