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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05118035
Other study ID # NDMC2021005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2021
Est. completion date December 31, 2022

Study information

Verified date February 2023
Source National Defense Medical Center, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for early detection of clinical deterioration for reducing mortality.


Recruitment information / eligibility

Status Completed
Enrollment 15965
Est. completion date December 31, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients in emergency department or inpatient department. - Patients recieved at least 1 ECG examination. Exclusion Criteria: - The patients recieved ECG at the period of inactive AI-ECG system.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
AI-enabled ECG-based Screening Tool
Primary care clinicians in the intervention group had access to the report, which shows the risk prediction results for each patients. Moreover, the clinicians will recieve a short message when patients with a high risk ECG identified by AI.

Locations

Country Name City State
Taiwan National Defense Medical Center Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary All cause mortality (death) After performing an electrocardiogram, the patient's survival is tracked. Within 90 days
Secondary Cardiovascular cause mortality (death) After performing an electrocardiogram, the patient's survival is tracked. Within 90 days
Secondary Arrhythmia medication After performing an electrocardiogram, the patient recieved related intervention. Within 12 hours
Secondary Electrolyte examination After performing an electrocardiogram, the patient recieved electrolyte examination Within 3 days
Secondary Cadiac examination After performing an electrocardiogram, the patient recieved cadiac examination Within 3-7 days
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