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NCT05675670 Clinical Trial

Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism

Hyperthyroidism Clinical Trial

Official title:
Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05675670
Other study ID # NDMC2022001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date December 31, 2024

Study information
Verified date March 2023
Source National Defense Medical Center, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

hyperthyroidism

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 35000
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• AI-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.

Locations
Country Name City State
Taiwan Tri-Service General Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary New-onset hyperthyroidism A TSH of <0.25 IU/L Within 30 days
Primary New-onset anti-throid drug treatment New anti-throid drug treatment for patients with subclinical hyperthyroidism Within 60 days
Secondary All-cause mortality All-cause mortality Within 1 year.
Secondary Cardiac event Heart failure, arrhythmia, etc. Within 1 year.
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