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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontreal Heart Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Family Physicians or Nurse Practitioners

Trial design

Design model

Parallel

Treatments tested in this trial

  • DeepECG plateform diagnosis & recommendations

    Device

    EchoNeXT\& ECG-AI algorithm

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: No DeepECG plateform diagnosis & recommendationsNo intervention 0 interventions
Group B: DeepECG plateform diagnosis & recommendationsExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
18 months

Secondary outcomes

1

specificity, negative predictive value, and positive predictive value of cardiology referrals

Compare the specificity, negative predictive value, and positive predictive value of cardiology referrals made by family physicians and nurse practitioners before and after the activation of AI-assisted diagnostics and recommendations.

Time frame
18 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: