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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hyperthyroidism

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.