Deployment and Evaluation of Artificial Intelligence Software for Electrocardiogram Analysis and Management in Primary Care
DAISEA-ECG
1 other identifier
interventional
2,000
1 country
1
Brief Summary
The DAISEA-ECG project aims to improve the diagnosis of heart diseases in primary care through the DeepECG platform, which combines ECG-AI and ECHONeXT algorithms. This study uses a stepped wedge design, where each Family Medicine Group acts as its own control. The FMGs will gradually transition from the control period (without AI recommendations) to the intervention period (with AI recommendations activated) in a randomized sequence. The primary objective is to compare the sensitivity of family physicians in detecting cardiac pathologies, with and without the assistance of the DeepECG platform. Sensitivity is defined as the proportion of patients correctly referred to cardiology or for transthoracic echocardiography (TTE) among those who indeed required cardiovascular evaluation, as confirmed by an independent adjudication committee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedStudy Start
First participant enrolled
October 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
September 19, 2025
September 1, 2025
1.2 years
October 9, 2024
September 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
sensitivity of cardiology referrals
Compare the sensitivity of cardiology referrals made by family physicians and nurse practitioners before and after the activation of AI-assisted diagnostics and recommendations from the DeepECG platform.
18 months
Secondary Outcomes (1)
specificity, negative predictive value, and positive predictive value of cardiology referrals
18 months
Study Arms (2)
No DeepECG plateform diagnosis & recommendations
NO INTERVENTIONDeepECG plateform diagnosis & recommendations
EXPERIMENTALInterventions
EchoNeXT\& ECG-AI algorithm
Eligibility Criteria
You may qualify if:
- Family Physicians or Nurse Practitioners
- Family physicians or nurse practitioners (NPs) practicing in one of the participating FMGs.
- Family physicians who have given their free and informed consent. Patients
- Adult patients (18 years or older). Patients without follow-up in cardiology or internal medicine for cardiovascular issues (arrhythmia, heart failure, myocardial infarction, atherosclerotic coronary artery disease, valvular heart disease) or those who had a negative investigation in the past with no additional follow-up.
- ECG
- Any 12-lead ECG performed with the MUSE GE 360 machine. ECG of adequate technical quality for interpretation (otherwise, it will be automatically rejected by the platform).
You may not qualify if:
- Family Physicians or Nurse Practitioners
- Family physicians practicing exclusively in pediatrics (patients under 18 years old).
- Family physicians unable to follow the project guidelines.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montreal Heart Institute
Montreal, Quebec, H1T1C8, Canada
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Interventional cardiologist
Study Record Dates
First Submitted
October 9, 2024
First Posted
October 15, 2024
Study Start
October 6, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share