Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism

Not Applicable

Active, not recruiting

• Conditions: Hyperthyroidism
• Interventions: Other: AI-enabled ECG-based Screening Tool

• Registration Number: NCT05675670
• Lead Sponsor: National Defense Medical Center, Taiwan

Brief Summary

hyperthyroidism

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2022-12-29
• Study First Posted: 2023-01-09
• Status Verified: 2023-03
• Study Start: 2023-03-01
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35000

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	AI-enabled ECG-based Screening Tool	Patients randomized to intervention will have access to the screening tool

Primary Outcome Measures

Name	Time	Method
New-onset hyperthyroidism	Within 30 days	A TSH of \<0.25 IU/L
New-onset anti-throid drug treatment	Within 60 days	New anti-throid drug treatment for patients with subclinical hyperthyroidism

Secondary Outcome Measures

Name	Time	Method
Cardiac event	Within 1 year.	Heart failure, arrhythmia, etc.
All-cause mortality	Within 1 year.	All-cause mortality

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan