Cardiac Auscultation Using Smartphones | NCT03273803

Studies
Cardiac Auscultation Using Smartphones

NCT03273803

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Sep 8, 2017Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Cardiovascular Physiological Phenomena

Interventions

Heart sound recording using smartphone application

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 24, 2016Actual

Primary Completion Date

Oct 31, 2016Actual

Completion Date

Jun 8, 2017Actual

First Submitted Date

Sep 3, 2017

First Submission Date that Met QC Criteria

Sep 3, 2017

First Posted Date

Sep 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2017

Last Update Posted Date

Sep 8, 2017Actual

Name	Class
Korea Advanced Institute of Science and Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Heart sound recording was done by researchers who were familiar with the use of the app and understand the principles of cardiac auscultation.

Reference 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Heart sound recording using smartphone application	Diagnostic Test	Heart sound recording and analysis using android smartphones (Samsung Galaxy S5, Galaxy S6, and LG G3)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of "CPstethoscope" in interpretation of heart sounds	specificity, sensitivity, negative predictive value, positive predictive value	0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects who gave informed consent
subjects who are 18 years old or older and had performed ECG and echocardiography during the previous 6 months.

Exclusion Criteria:

subjects with impairment of cognition

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Men and women were evenly enrolled, and the median age was 65.5 years.

Twenty subjects (43.5%) had systolic murmur, 20 (43.5%) normal heart sound, 5 (10.9%) diastolic murmur, and 1 (2.2%) S4.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jung-Won Suh, MD, PhD	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463707	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29490899	Derived	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.