Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
Study NCT ID:
NCT06567106
Status:
RECRUITING
Last Update Posted:
2024-11-04
First Post:
2024-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-10', 'size': 177011, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_001.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-10-11T02:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and outcomes assessors are blinded to the experimental condition.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each participant is randomly assigned to receive either ultrasound intervention at varying intensities or sham control.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-19', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rhythm.', 'timeFrame': 'Throughout the intervention, an average of 1 hour.', 'description': "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."}, {'measure': 'Incidence of treatment-related adverse events.', 'timeFrame': 'Baseline, during the intervention (an average of 1 hour) and immediately after the intervention (same day, approximately 1 hour after baseline).', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'Heart', 'Cardiac function'], 'conditions': ['Cardiac Function']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate the influence of ultrasound on cardiac functrion.\n\nThe main question it aims to answer is:\n\nHow will ultrasound affect the cardiac function?\n\nResearchers will： Apply ultrasound to the body and observe cardiac functions.\n\nParticipants will:\n\nReceive ultrasound application and physiological signal monitoring.', 'detailedDescription': '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).\n\nThe 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals without significant diseases or chronic conditions.\n* Aged between 18 and 65 years.\n* Voluntary participation with signed informed consent.\n* No history of cardiovascular disease.\n\nExclusion Criteria:\n\n* Individuals with heart disease or other conditions that may affect cardiac function measurement.\n* Individuals with implanted electronic devices such as pacemakers or defibrillators.\n* Those on medications that significantly alter heart rate, such as beta-blockers, unless under stable control for a specific period.\n* Individuals at risk of severe complications.'}, 'identificationModule': {'nctId': 'NCT06567106', 'briefTitle': 'Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention', 'organization': {'class': 'OTHER', 'fullName': 'ShanghaiTech University'}, 'officialTitle': 'Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention', 'orgStudyIdInfo': {'id': 'Q2024-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound application at minimal intensity', 'description': 'Apply minimal-intensity ultrasound to the participant. The intensity is below 2 W/cm².', 'interventionNames': ['Other: Ultrasound application']}, {'type': 'EXPERIMENTAL', 'label': 'Ultrasound application at mild intensity', 'description': 'Apply mild-intensity ultrasound to the participant. The intensity is below 3 W/cm².', 'interventionNames': ['Other: Ultrasound application']}, {'type': 'SHAM_COMPARATOR', 'label': 'Ultrasound application at medium intensity', 'description': 'Apply medium-intensity ultrasound to the participant. The intensity is below 5 W/cm².', 'interventionNames': ['Other: Ultrasound application']}, {'type': 'SHAM_COMPARATOR', 'label': 'No ultrasound application', 'description': 'No ultrasound application to the participant.', 'interventionNames': ['Other: No ultrasound application']}], 'interventions': [{'name': 'Ultrasound application', 'type': 'OTHER', 'description': 'Apply ultrasound to the participant within a safe range.', 'armGroupLabels': ['Ultrasound application at medium intensity', 'Ultrasound application at mild intensity', 'Ultrasound application at minimal intensity']}, {'name': 'No ultrasound application', 'type': 'OTHER', 'description': 'No ultrasound application to the participant.', 'armGroupLabels': ['No ultrasound application']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bingbing Cheng, Ph.D.', 'role': 'CONTACT', 'email': 'chengbb@shanghaitech.edu.cn'}], 'facility': 'Bingbing Cheng', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Bingbing Cheng, Ph.D.', 'role': 'CONTACT', 'email': 'chengbb@shanghaitech.edu.cn', 'phone': '+8620685173'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ShanghaiTech University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Bingbing Cheng', 'investigatorAffiliation': 'ShanghaiTech University'}}}}