Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Dyskalemia

Sponsor
National Defense Medical Center, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05118022
Collaborator
(none)
84,000
1
2
24.7
3399.9

Study Details

Study Description

Brief Summary

This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of potassium abnormalities.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84000 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 Dyskalemia
Actual Study Start Date :
Dec 9, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

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.

Outcome Measures

Primary Outcome Measures

  1. Time to treatment [Within 6 hours]

    treatment time

Secondary Outcome Measures

  1. Sudden death [Within 3 days]

    death

  2. All cause mortality [Within 365 days]

    After detecting the abnormal potassium electrocardiogram, the survival status was tracked.

  3. Number of electric shocks [Within 6 hours]

    electric shocks times

  4. Number of CPRs performed [Within 6 hours]

    performe CPR

  5. The length of hospitalization [Within 365 days]

    The length of hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All Patients
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Defense Medical Center Taipei Taiwan 114

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:
NCT05118022
Other Study ID Numbers:
  • NDMC2021004
First Posted:
Nov 11, 2021
Last Update Posted:
Dec 22, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 22, 2021