NCT05675670

Brief Summary

hyperthyroidism

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

December 26, 2022

Last Update Submit

March 21, 2023

Conditions

Hyperthyroidism

Outcome Measures

Primary Outcomes (2)

  • New-onset hyperthyroidism

    A TSH of \<0.25 IU/L

    Within 30 days

  • New-onset anti-throid drug treatment

    New anti-throid drug treatment for patients with subclinical hyperthyroidism

    Within 60 days

Secondary Outcomes (2)

  • All-cause mortality

    Within 1 year.

  • Cardiac event

    Within 1 year.

Study Arms (2)

Intervention

EXPERIMENTAL

Patients randomized to intervention will have access to the screening tool

Other: AI-enabled ECG-based Screening Tool

Control

NO INTERVENTION

Patients randomized to control will continue routine practice.

Interventions

AI-enabled ECG-based Screening ToolOTHER

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Hyperthyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 26, 2022

First Posted

January 9, 2023

Study Start

March 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)