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 |
---|---|---|
|
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
- Time to treatment [Within 6 hours]
treatment time
Secondary Outcome Measures
- Sudden death [Within 3 days]
death
- All cause mortality [Within 365 days]
After detecting the abnormal potassium electrocardiogram, the survival status was tracked.
- Number of electric shocks [Within 6 hours]
electric shocks times
- Number of CPRs performed [Within 6 hours]
performe CPR
- 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: