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Active, not recruitingNCT05675670Updated Mar 23, 2023

Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism

An interventional study of AI-enabled ECG-based Screening Tool in Hyperthyroidism, sponsored by National Defense Medical Center, Taiwan. Active, not recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by National Defense Medical Center, Taiwan · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
35,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

hyperthyroidism

02

Conditions studied

  • Hyperthyroidism

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03

In context

Hyperthyroidism

111 studies on the registry are indexed under Hyperthyroidism; 28 are open to participants now.

This study's planned enrollment of 35,000 is above the median of 60 across 54 interventional studies indexed under Hyperthyroidism.

Browse Hyperthyroidism studies →

Lead sponsor

National Defense Medical Center, Taiwan is the lead sponsor of 63 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients in outpatient department.
  • Patients recieved at least 1 ECG examination.
  • Patients without TSH test before ECG examination or patients with subclinical hyperthyroidism without anti-thyroid drug usage.

Exclusion criteria

Exclusion Criteria:

  • The patients recieved ECG at the period of inactive AI-ECG system.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35,000 participants (estimated)

Study arms

  • Experimental
    Intervention

    Patients randomized to intervention will have access to the screening tool

    Other: AI-enabled ECG-based Screening Tool

  • No intervention
    Control

    Patients randomized to control will continue routine practice.

Interventions

  • OtherAI-enabled ECG-based Screening Tool

    Primary care clinicians in the intervention group had access to the report, which displayed whether the AI-ECG result was positive or negative. The system will send a message to corresponding physicians if positive finding.

06

What researchers measure

Primary outcomes

  1. New-onset hyperthyroidism

    A TSH of \<0.25 IU/L

    Time frame: Within 30 days

  2. New-onset anti-throid drug treatment

    New anti-throid drug treatment for patients with subclinical hyperthyroidism

    Time frame: Within 60 days

Secondary outcomes

  1. All-cause mortality

    All-cause mortality

    Time frame: Within 1 year.

  2. Cardiac event

    Heart failure, arrhythmia, etc.

    Time frame: Within 1 year.

07

Study locations

1 site
  • Tri-Service General Hospital
    Taipei, 114, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05675670
Lead sponsor
National Defense Medical Center, Taiwan
Responsible party
Chin Lin (Assistant Professor, National Defense Medical Center, Taiwan) — Principal investigator
First posted
Jan 9, 2023
Start date
Mar 1, 2023
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 23, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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