NCT03273803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

2 months

First QC Date

September 3, 2017

Last Update Submit

September 5, 2017

Conditions

Cardiovascular Physiological Phenomena

Keywords

Heart sounds, smartphone, application

Outcome Measures

Primary Outcomes (1)

  • Accuracy of "CPstethoscope" in interpretation of heart sounds

    specificity, sensitivity, negative predictive value, positive predictive value

    0

Interventions

Heart sound recording using smartphone applicationDIAGNOSTIC_TEST

Heart sound recording and analysis using android smartphones (Samsung Galaxy S5, Galaxy S6, and LG G3)

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • subjects with impairment of cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463707, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29490899DERIVED

Study Officials

  • Jung-Won Suh, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 3, 2017

First Posted

September 6, 2017

Study Start

August 24, 2016

Primary Completion

October 31, 2016

Study Completion

June 8, 2017

Last Updated

September 8, 2017

Record last verified: 2017-09

Locations

KR(1)