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Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism

Primary Purpose

Hyperthyroidism

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
AI-enabled ECG-based Screening Tool
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hyperthyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tri-Service General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Patients randomized to intervention will have access to the screening tool

Patients randomized to control will continue routine practice.

Outcomes

Primary Outcome Measures

New-onset hyperthyroidism
A TSH of <0.25 IU/L
New-onset anti-throid drug treatment
New anti-throid drug treatment for patients with subclinical hyperthyroidism

Secondary Outcome Measures

All-cause mortality
All-cause mortality
Cardiac event
Heart failure, arrhythmia, etc.

Full Information

First Posted
December 26, 2022
Last Updated
March 21, 2023
Sponsor
National Defense Medical Center, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05675670
Brief Title
Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism
Official Title
Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
hyperthyroidism

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthyroidism

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients randomized to intervention will have access to the screening tool
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients randomized to control will continue routine practice.
Intervention Type
Other
Intervention Name(s)
AI-enabled ECG-based Screening Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
New-onset hyperthyroidism
Description
A TSH of <0.25 IU/L
Time Frame
Within 30 days
Title
New-onset anti-throid drug treatment
Description
New anti-throid drug treatment for patients with subclinical hyperthyroidism
Time Frame
Within 60 days
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
All-cause mortality
Time Frame
Within 1 year.
Title
Cardiac event
Description
Heart failure, arrhythmia, etc.
Time Frame
Within 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism

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