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Recruiting NCT06567106

Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention

No phase Interventional Cardiac Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound application, No ultrasound application.
Who it may be relevant to
Registry conditions: Cardiac Function. Basic parameters: 18 years — 65 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Detailed description

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.

Interventions

  • Other Ultrasound application
    Apply ultrasound to the participant within a safe range.
  • Other No ultrasound application
    No ultrasound application to the participant.

Primary outcome measures

  • Heart rhythm. [Time frame: Throughout the intervention, an average of 1 hour.]
  • 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Bingbing Cheng — Shanghai

Identifiers

NCT: NCT06567106 · Q2024-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗