Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-30 @ 12:26 AM
Study NCT ID:
NCT06422468
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-05-14', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of morphologic characteristics of smartphone generated signals', 'timeFrame': '1 day', 'description': 'Detect or identify specific morphologic characteristics (changes or correlations) by the comparison of PPG signals, accelerometer signals, gyroscope signals, sound signals and ECG signals, derived via the smartphone data.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the performance of the FibriCheck Algorithm', 'timeFrame': '1 day', 'description': 'Evaluate the performance of our PPG FibriCheck Algorithm in cardiology patients and healthy volunteers, based on simultaneously recorded ECG data (RR intervals).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Photoplethysmography', 'Single-lead Electrocardiography'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional clinical trial is to investigate whether combining photoplethysmography (PPG) signals with accelerometer (ACC), gyroscope (GYR), sound, and electrocardiography (ECG) derived smartphone data provides additional insights into the cardiac condition of individuals with and without atrial fibrillation (AF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria applicable for all groups:\n\n* At least 18 years old\n* Participants must have the ability to understand and provide written informed consent\n* Participants must have the ability to understand Dutch\n\nGroup specific inclusion criteria:\n\nGroup 1: Healthy volunteers\n\n* No cardiac conditions based on medical history.\n\nGroup 2: Cardiology patients\n\n* Patients at the consultation or ambulatory unit of Cardiology (pre- cardioversion, pre-pulmonary vein isolation) with AF.\n* Patients without AF but with a current cardiac condition (e.g. heart failure with a reduced or preserved ejection fraction) or a history of a cardiac condition (e.g. history of myocardial infarction).\n\nExclusion Criteria:\n\n* Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device\n* Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement\n* Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow\n* Persons that have a disability to perform the measurements according to the instructions for use\n* Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm'}, 'identificationModule': {'nctId': 'NCT06422468', 'acronym': 'CARDS-pilot', 'briefTitle': 'Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qompium NV'}, 'officialTitle': 'Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring: a Pilot Study', 'orgStudyIdInfo': {'id': 'Z-2023103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FibriCheck recordings', 'interventionNames': ['Device: FibriCheck recordings']}], 'interventions': [{'name': 'FibriCheck recordings', 'type': 'DEVICE', 'description': 'PPG, ACC, GYR, ECG and sound measurements', 'armGroupLabels': ['FibriCheck recordings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Pieter Vandervoort, MD', 'role': 'CONTACT', 'email': 'pieter.vandervoort@zol.be', 'phone': '089/325050'}], 'facility': 'Ziekenhuis Oost Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}], 'centralContacts': [{'name': 'Lars Grieten, PhD', 'role': 'CONTACT', 'email': 'Lars.Grieten@fibricheck.com', 'phone': '+3211485953'}, {'name': 'Annelies Geeraerts, PhD', 'role': 'CONTACT', 'email': 'Annelies.Geeraerts@fibricheck.com', 'phone': '+3211485953'}], 'overallOfficials': [{'name': 'Pieter Vandervoort, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziekenhuis Oost-Limburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qompium NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}