Primary Care ProviderDAISEA-ECGNCT06637293
Deployment and Evaluation of Artificial Intelligence Software for Electrocardiogram Analysis and Management in Primary Care
A study testing DeepECG plateform diagnosis & recommendations in people with Primary Care Provider and Structural Heart Disease, run by Montreal Heart Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Care Provider, Structural Heart Disease
- What is being tested?
- DeepECG plateform diagnosis & recommendations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2025to Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- -
Who cannot join
- Family Physicians or Nurse Practitioners
- Family physicians practicing exclusively in pediatrics (patients under 18 years old).
- Family physicians unable to follow the project guidelines.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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
- Conditions
- Primary Care Provider, Structural Heart Disease
- Being tested
- DeepECG plateform diagnosis & recommendations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeepECG plateform diagnosis & recommendationsDevice
EchoNeXT\& ECG-AI algorithm
| Study group | Role | What they receive |
|---|---|---|
| No DeepECG plateform diagnosis & recommendations | No intervention | Not described |
| DeepECG plateform diagnosis & recommendations | Experimental | Not described Receives: Device: DeepECG plateform diagnosis & recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start2 Oct 2025
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Care ProviderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- stepped wedge randomization
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Avram, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637293
- Sponsor's protocol ID
- DAISEA-ECG
- Acronym
- DAISEA-ECG
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No