NCT05320900

Brief Summary

The purpose is to establish chest auscultation data and related clinical data for diagnosing heart and lung diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

March 25, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

March 25, 2022

Last Update Submit

January 24, 2023

Conditions

Auscultation for Clinical Evaluation

Outcome Measures

Primary Outcomes (1)

  • Incidence of valvular heart disease

    Echocardiography, coronary CTA, coronary angiography and other examinations find direct evidence of coronary artery stenosis, which can confirm the diagnosis

    Within one week of echocardiography

Study Arms (3)

Severance hospital

Cardiovascular disease patients

Diagnostic Test: Chest auscultation

Yongin Severance hospital

Cardiovascular disease patients

Diagnostic Test: Chest auscultation

Soon Chun Hyang University Hospital Bucheon

Cardiovascular disease patients

Diagnostic Test: Chest auscultation

Interventions

Chest auscultationDIAGNOSTIC_TEST

Chest auscultation data

Severance hospitalSoon Chun Hyang University Hospital BucheonYongin Severance hospital

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who obtained chest auscultation will be enrolled.

You may qualify if:

  • Adults who are 20 years and older

You may not qualify if:

  • Patient refusal
  • Uncertain radiographs
  • Uncertain tests results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yongin Severance Hospital

Yŏngin, Giheung-gu, 16995, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Study Officials

  • Hyuk-Jae Chang, MD, PhD

    Severance Hospital, Yonsei University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 11, 2022

Study Start

May 1, 2022

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(3)