Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-03-05 @ 7:51 AM
Study NCT ID:
NCT03273803
Status:
COMPLETED
Last Update Posted:
2017-09-08
First Post:
2017-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Auscultation Using Smartphones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-05', 'studyFirstSubmitDate': '2017-09-03', 'studyFirstSubmitQcDate': '2017-09-03', 'lastUpdatePostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of "CPstethoscope" in interpretation of heart sounds', 'timeFrame': '0', 'description': 'specificity, sensitivity, negative predictive value, positive predictive value'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart sounds, smartphone, application'], 'conditions': ['Cardiovascular Physiological Phenomena']}, 'referencesModule': {'references': [{'pmid': '29490899', 'type': 'DERIVED', 'citation': 'Kang SH, Joe B, Yoon Y, Cho GY, Shin I, Suh JW. Cardiac Auscultation Using Smartphones: Pilot Study. JMIR Mhealth Uhealth. 2018 Feb 28;6(2):e49. doi: 10.2196/mhealth.8946.'}]}, 'descriptionModule': {'briefSummary': 'The investigators performed a proof-of-concept study enrolling subjects with normal and pathologic heart sounds. Heart sound was recorded by auscultation on the skin of the chest wall using three smartphones: Samsung Galaxy S5 and Galaxy S6, and LG G3 . Recorded heart sounds were processed and classified by a diagnostic algorithm using convolutional neural networks.', 'detailedDescription': 'Heart sound recording was done by researchers who were familiar with the use of the app and understand the principles of cardiac auscultation.\n\nReference heart sounds were recorded using an electronic stethoscope (3M™ Littmann® Electronic Stethoscope Model 3200). Study devices included Samsung Galaxy S5 (model SM-G900), Galaxy S6 (SM-G920), and LG G3 (LG-F400).'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women were evenly enrolled, and the median age was 65.5 years.\n\nTwenty subjects (43.5%) had systolic murmur, 20 (43.5%) normal heart sound, 5 (10.9%) diastolic murmur, and 1 (2.2%) S4.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects who gave informed consent\n* subjects who are 18 years old or older and had performed ECG and echocardiography during the previous 6 months.\n\nExclusion Criteria:\n\n* subjects with impairment of cognition'}, 'identificationModule': {'nctId': 'NCT03273803', 'briefTitle': 'Cardiac Auscultation Using Smartphones', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Cardiac Auscultation Using Smartphones: a Proof-of-concept Study', 'orgStudyIdInfo': {'id': 'B-1609-361-303'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Heart sound recording using smartphone application', 'type': 'DIAGNOSTIC_TEST', 'description': 'Heart sound recording and analysis using android smartphones (Samsung Galaxy S5, Galaxy S6, and LG G3)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '463707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Jung-Won Suh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korea Advanced Institute of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jung-Won Suh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}