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NCT Number: NCT06637293

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location contact

Marie-Gabrielle Lessard, MSc

CONTACT

[email protected]

5143763330 ext. 2094

Robert Avram, MD

PRINCIPAL_INVESTIGATOR

About this study

Mathematically, sensitivity is calculated as True Positive / (True Positive + False Negative), where True Positive represents correctly referred patients and false negatives represents patients who should have been referred but were not.

The secondary objectives include determining the rate of cardiovascular evaluation referrals before and after the intervention (implementation of the DeepECG platform), the individual characteristics of the intervention (PPV, NPV, and specificity), as well as evaluating the feasibility of implementing AI-based automatic ECG interpretation in primary care through surveys of family physicians and cardiologists.

PPV: Positive predictive value NPV: Negative predictive value

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

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Exclusion criteria

  • Family Physicians or Nurse Practitioners

Family physicians practicing exclusively in pediatrics (patients under 18 years old).

Family physicians unable to follow the project guidelines.

Treatment and study plan

DeepECG plateform diagnosis & recommendations

Device

EchoNeXT& ECG-AI algorithm

Primary outcomes

  1. sensitivity of cardiology referrals

    Time frame: 18 months

    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.

Secondary outcomes

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

    Time frame: 18 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Gabrielle Lessard, MSc

CONTACT

[email protected]

514 376 3330 ext. 2094

Robert Avram, MD

CONTACT

[email protected]

514 376 3330

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Acronym: DAISEA-ECG

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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