Applying an Artificial Intelligence-Enabled Electrocardiographic System for Reducing Mortality

Cardiovascular Diseases Clinical Trial

Official title:

Applying an Artificial Intelligence-Enabled Electrocardiographic System for Reducing Mortality: a Pragmatic Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05118035
• Other study ID #: NDMC2021005
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Morality

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