Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06462989 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Harnessing ECG Artificial Intelligence for Rapid Treatment and Accurate Interpretation

Study acronym: HEART-AI
StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 10 months later Jan 31, 2026 → Dec 2027
Primary endpoint reworded 1 of 1 changed
Enrollment reduced 65% 16160 → 5700 participants
See other at-risk trials from Montreal Heart Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jan 31, 2026 to Dec 2027 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment reduced: 16160 → 5700 participants
    • Study completion pushed from Jan 31, 2027 to Dec 2027
    • Eligibility criteria shortened, about 110 words
    • Secondary endpoints: 5 to 17
    • Study description expanded, about 384 words
    • Study title shortened, about 4 words
  2. Study description expanded, about 8 words
    • Eligibility criteria expanded, about 4 words
    v5
  3. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Jan 2025 to Apr 16, 2025
    • Eligibility criteria shortened, about 21 words
    • Site contact updated
    v4
  4. Study title expanded, about 4 wordsv3
  5. Enrollment target: 10200 to 16160v2 Show 7 more changesShow less
    • Start date: Jul 1, 2024 to Jan 2025
    • Primary endpoints: 2 to 1
    • Interventions: ECHONEXT (Device) to ECHONEXT (Other)
    • Eligibility criteria expanded, about 54 words
    • Secondary endpoints expanded, about 94 words
    • Study description shortened, about 9 words
    • Study title shortened, about 6 words
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
HEART-AI is a pragmatic randomized trial currently active at Montreal Heart Institute, with planned multicenter expansion testing whether an artificial intelligence (AI) score from a routine 12-lead electrocardiogram (ECG) helps clinicians identify structural heart disease sooner. Structural heart disease includes reduced heart pumping function, valve disease, pulmonary hypertension, thickened heart muscle and fluid around the heart. The study plans to enroll 5,700 adults seen in outpatient clinics or ambulatory emergency departments who have no known structural heart disease. Patients are assigned equally to standard care with or without the EchoNext AI risk score and echocardiography recommendation. For high-risk patients, EchoNext recommends a transthoracic echocardiogram (TTE, an ultrasound of the heart) within 2 to 4 weeks, no later than 30 days. Low-risk patients receive routine care, with TTE when clinically indicated. Clinicians retain responsibility for all care decisions. The score is calculated in both groups but shown only in the AI group. The main outcome is the proportion of patients with structural heart disease documented on a clinical TTE within 30 days of their first study ECG. Other outcomes include diagnoses within 12 months, time to TTE and diagnosis, imaging use, management changes and model performance.
Trial Details
NCT Number NCT06462989
Lead Sponsor Montreal Heart Institute
Conditions
(from sponsor)		 Structural Heart Abnormality, Structural Heart Disease
Enrollment 5,700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov