Cardiac FunctionNCT06567106
Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention
A study testing Ultrasound application and No ultrasound application in people with Cardiac Function, run by ShanghaiTech University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Function
- What is being tested?
- Ultrasound application and No ultrasound application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 10 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Bingbing Cheng
Shanghai
Bingbing Cheng, Ph.D., chengbb@shanghaitech.edu.cn
About this study
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.
Read the 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.
- Conditions
- Cardiac Function
- Being tested
- Ultrasound application, No ultrasound application
- Keywords
- Ultrasound, Heart, Cardiac function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound applicationOther
Apply ultrasound to the participant within a safe range.
No ultrasound applicationOther
No ultrasound application to the participant.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound application at minimal intensity | Experimental | Apply minimal-intensity ultrasound to the participant. The intensity is below 2 W/cm². Receives: Other: Ultrasound application |
| Ultrasound application at mild intensity | Experimental | Apply mild-intensity ultrasound to the participant. The intensity is below 3 W/cm². Receives: Other: Ultrasound application |
| Ultrasound application at medium intensity | Sham comparator | Apply medium-intensity ultrasound to the participant. The intensity is below 5 W/cm². Receives: Other: Ultrasound application |
| No ultrasound application | Sham comparator | No ultrasound application to the participant. Receives: Other: No ultrasound application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline, during the intervention (an average of 1 hour) and immediately after the intervention (same day, approximately 1 hour after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start10 Oct 2024
- Primary completion10 Oct 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant is randomly assigned to receive either ultrasound intervention at varying intensities or sham control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShanghaiTech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bingbing Cheng, ShanghaiTech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567106
- Sponsor's protocol ID
- Q2024-004
- Status last verified
- Oct 2024
- First submitted
- 14 Aug 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention
- ClinicalTrials.gov ID
- NCT06567106
- Acronym / sponsor ID
- Q2024-004
- Conditions
- Cardiac Function
- Keywords
- Ultrasound, Heart, Cardiac function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- ShanghaiTech UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Each participant is randomly assigned to receive either ultrasound intervention at varying intensities or sham control.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound application at minimal intensity | Experimental | Other: Ultrasound applicationApply minimal-intensity ultrasound to the participant. The intensity is below 2 W/cm². |
| Ultrasound application at mild intensity | Experimental | Other: Ultrasound applicationApply mild-intensity ultrasound to the participant. The intensity is below 3 W/cm². |
| Ultrasound application at medium intensity | Sham comparator | Other: Ultrasound applicationApply medium-intensity ultrasound to the participant. The intensity is below 5 W/cm². |
| No ultrasound application | Sham comparator | Other: No ultrasound applicationNo ultrasound application to the participant. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound applicationApply ultrasound to the participant within a safe range. | Other | Ultrasound application at medium intensity, Ultrasound application at mild intensity, Ultrasound application at minimal intensity |
| No ultrasound applicationNo ultrasound application to the participant. | Other | No ultrasound application |
Primary outcome
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Cardiac Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound application and No ultrasound application in people with Cardiac Function, run by ShanghaiTech University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bingbing Cheng, Ph.D. (+8620685173, chengbb@shanghaitech.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rhythm. (time frame: Throughout the intervention, an average of 1 hour.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.