NCT06650618

Brief Summary

Electrical conduction in the heart produces a heartbeat; electrical signals are sent to the heart muscle upon each contraction, causing the heart to pump blood. These electrical impulses are recorded by an electrocardiogram (ECG), which makes it possible to evaluate electrical conduction and cardiac rhythm. ECG is a non-invasive technique used to assess pacemaker function and perioperative heart health. Ten electrodes are used in the 12-lead ECG, the gold standard for diagnosing cardiac illness and anatomy, to record the electrical activity of the heart from various perspectives. With wireless data transmission to the cloud, this technology is now included into emergency and ambulance situations, streamlining processes and improving signal quality. The purpose of this observational study is to examine 12-lead electrocardiogram data for better clinical application and diagnosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

September 25, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

October 31, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 21, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

September 25, 2024

Last Update Submit

October 18, 2024

Conditions

Keywords

ECGheart rhythmelectrical conduction

Outcome Measures

Primary Outcomes (1)

  • ECG change related to position

    ECG ST segment elevation or depression might be attributed to varying body postures. The ST segments\' change to baseline will be compared by the investigators.

    through study completion, an average of 30 minutes.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants without diagnosed arrhythmia, ischemic heart disease, congestive heart failure or pending for all kinds of heart surgery.

You may qualify if:

  • Adults 18\~65 years of age
  • Fluent in either Taiwanese/Chinese/English.

You may not qualify if:

  • Pregnancy
  • Refusal to give informed consent
  • Candidate for coronary bypass surgery or valves surgery or other cardiac surgery
  • Participants with diagnosed arrhythmia, ischemic heart disease or congestive heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, 80756, Taiwan

Location

Study Officials

  • Tzu-Ying Li

    Kaohsiung Medical University Chung-Ho Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2024

First Posted

October 21, 2024

Study Start

October 31, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Statistical Analysis Plan can be shared

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 3 months and ending 1 year after the publication of results
Access Criteria
Researchers with formal inquiry will be able to access it.

Locations