Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism

Sponsor

National Defense Medical Center, Taiwan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05675670

Collaborator

(none)

35,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

hyperthyroidism

Condition or Disease	Intervention/Treatment	Phase
Hyperthyroidism	Other: AI-enabled ECG-based Screening Tool	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Patients randomized to intervention will have access to the screening tool	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.
No Intervention: Control Patients randomized to control will continue routine practice.

Arm

Intervention/Treatment

Experimental: Intervention

Patients randomized to intervention will have access to the screening tool

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.

No Intervention: Control

Patients randomized to control will continue routine practice.

Outcome Measures

Primary Outcome Measures

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

All-cause mortality [Within 1 year.]
All-cause mortality
Cardiac event [Within 1 year.]
Heart failure, arrhythmia, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Defense Medical Center, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chin Lin, Assistant Professor, National Defense Medical Center, Taiwan

ClinicalTrials.gov Identifier:

NCT05675670

Other Study ID Numbers:

NDMC2022001

First Posted:

Jan 9, 2023

Last Update Posted:

Jan 9, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperthyroidism

Study Results

No Results Posted as of Jan 9, 2023