Cardiovascular Physiological PhenomenaNCT03273803
Cardiac Auscultation Using Smartphones
An observational study of Cardiovascular Physiological Phenomena, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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 . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Physiological Phenomena
- What is being tested?
- Heart sound recording using smartphone application
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Aug 2016to 8 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older 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.
Who may be able to join
- subjects who gave informed consent
- subjects who are 18 years old or older and had performed ECG and echocardiography during the previous 6 months.
Who cannot join
- subjects with impairment of cognition
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463707
About this study
Official title: Cardiac Auscultation Using Smartphones: a Proof-of-concept Study
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.
Read the 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).
- Conditions
- Cardiovascular Physiological Phenomena
- Being tested
- Heart sound recording using smartphone application
- Keywords
- Heart sounds, smartphone, application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart sound recording using smartphone applicationDiagnostic test
Heart sound recording and analysis using android smartphones (Samsung Galaxy S5, Galaxy S6, and LG G3)
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of "CPstethoscope" in interpretation of heart sounds
specificity, sensitivity, negative predictive value, positive predictive value
Measured: 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start24 Aug 2016
- Primary completion31 Oct 2016
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Physiological PhenomenaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Advanced Institute of Science and Technology
- Responsible party
- Principal investigator, Jung-Won Suh, Seoul National University Hospital
- Investigators
- Jung-Won Suh, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273803
- Sponsor's protocol ID
- B-1609-361-303
- Status last verified
- Sep 2017
- First submitted
- 3 Sep 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29490899
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Auscultation Using Smartphones: a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT03273803
- Acronym / sponsor ID
- B-1609-361-303
- Conditions
- Cardiovascular Physiological Phenomena
- Keywords
- Heart sounds, smartphone, application
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korea Advanced Institute of Science and Technology
- Study start
- 24 Aug 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (2 listed)
- subjects who gave informed consent
- subjects who are 18 years old or older and had performed ECG and echocardiography during the previous 6 months.
Key exclusion criteria (1 listed)
- subjects with impairment of cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart sound recording using smartphone applicationHeart sound recording and analysis using android smartphones (Samsung Galaxy S5, Galaxy S6, and LG G3) | Diagnostic test | – |
Primary outcome
Accuracy of "CPstethoscope" in interpretation of heart sounds
Time frame: 0
specificity, sensitivity, negative predictive value, positive predictive value
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Derived from this study: PubMed 29490899Kang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Won Suh, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Physiological Phenomena, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of "CPstethoscope" in interpretation of heart sounds (time frame: 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03273803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.