Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention

NCT06567106 | Recruiting

• 1 other identifier: Q2024-004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Function

Keywords

Ultrasound; Heart; Cardiac function

Outcome Measures

Primary Outcomes (2)

• 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).

Study Arms (4)

Ultrasound application at minimal intensity

EXPERIMENTAL

Apply minimal-intensity ultrasound to the participant. The intensity is below 2 W/cm².

Other: Ultrasound application

Ultrasound application at mild intensity

EXPERIMENTAL

Apply mild-intensity ultrasound to the participant. The intensity is below 3 W/cm².

Other: Ultrasound application

Ultrasound application at medium intensity

SHAM COMPARATOR

Apply medium-intensity ultrasound to the participant. The intensity is below 5 W/cm².

Other: Ultrasound application

No ultrasound application

SHAM COMPARATOR

No ultrasound application to the participant.

Other: No ultrasound application

Interventions

Ultrasound application OTHER

Apply ultrasound to the participant within a safe range.

Ultrasound application at medium intensity; Ultrasound application at mild intensity; Ultrasound application at minimal intensity

No ultrasound application OTHER

No ultrasound application to the participant.

No ultrasound application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ShanghaiTech University: lead

Study Sites (1)

Bingbing Cheng

Shanghai, China

RECRUITING

Central Study Contacts

Bingbing Cheng, Ph.D.

CONTACT

+8620685173; chengbb@shanghaitech.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessors are blinded to the experimental condition.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Each participant is randomly assigned to receive either ultrasound intervention at varying intensities or sham control.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 22, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): October 10, 2027
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)