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NCT Number: NCT06567106

Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention

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.

Recruiting

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Key information

Conditions

Cardiac Function

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bingbing Cheng

Shanghai, China

Location status: Recruiting

Location contact

Bingbing Cheng, Ph.D.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound application

Other

Apply ultrasound to the participant within a safe range.

No ultrasound application

Other

No ultrasound application to the participant.

Primary outcomes

  1. Heart rhythm.

    Time frame: 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.

  2. Incidence of treatment-related adverse events.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Bingbing Cheng, Ph.D.

CONTACT

[email protected]

+8620685173

Sponsors and collaborators

Lead sponsor

ShanghaiTech University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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