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Deployment and Evaluation of Artificial Intelligence Software for Electrocardiogram Analysis and Management in Primary Care

Study acronym: DAISEA-ECG
StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Enrolling by invitation only Show 4 more changesShow less
    • Start date changed from estimate of Oct 6, 2025 to Oct 2, 2025
    • Interventions: DeepECG plateform diagnosis & recommendations (Device) to DeepECG plateform diagnosis & recommendations (Device)
    • Site contact updated
    • Eligibility criteria expanded, about 1 word
  2. Primary completion date: Jan 1, 2026 to Jan 2027
    • Start date: Dec 1, 2024 to Oct 6, 2025
    • Study completion date: Jan 1, 2026 to Mar 2027
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06637293
Lead Sponsor Montreal Heart Institute
Conditions
(from sponsor)		 Primary Care Provider, Structural Heart Disease
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov