The SMART-LV Pilot Study

Not Applicable

Completed

• Conditions: Left Ventricular Systolic Dysfunction

• Registration Number: NCT05630170
• Lead Sponsor: Yale University

Brief Summary

The goal of this pilot study is to evaluate the prospective performance of an image-based, smartphone-adaptable artificial intelligence electrocardiogram (AI-ECG) strategy to predict and detect left ventricular systolic dysfunction (LVSD) in a real-world setting.

Detailed Description

The SMART-LV pilot study will be a prospective cohort study in outpatient clinics at the Yale New Haven Hospital. Participants who have undergone a 12-lead electrocardiogram (ECGs) with either a high (≥80%) or low (\<10%) probability of LVSD on AI-ECG algorithm, but without an echocardiogram done in the clinical setting for at least 90 days after the ECG, will be identified by electronic health record (EHR) and invited for a limited echocardiogram/cardiac ultrasonogram for assessing LV ejection fraction. The goal of the study is to evaluate the feasibility of recruiting patients and performing the study after pursuing a screening on 12-lead ECGs. The procedure currently used for detection of LVSD, echocardiograms, are inaccessible and expensive. Therefore, while AI-ECG-based algorithms using a smartphone- or web-based application can broaden access to screening, a thorough evaluation for this indication is needed before clinical adoption. The investigators intend to use the results as pilot data for sample size and drop-off rate estimation for a subsequent larger prospective cohort study aimed at validating the performance characteristics of the model in a screening setting.

The validation of this accessible ECG-based screening strategy, that can be directly used by clinicians using a smartphone or web-based application, can transform the early identification of LVSD before the development of symptoms, thereby allowing broader utilization of evidence-based therapies to prevent symptomatic heart failure and premature death.

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-29
• Study Start: 2023-09-13
• Status Verified: 2024-05
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-22
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

• Patients who have undergone a prior echocardiogram.
• Patients with a prior diagnosis of left ventricular dysfunction, based on a documented low ejection fraction (EF) in the medical record.
• Patients with an intermediate predicted probability of low EF (10 to 80%)
• Patients with a prior diagnosis of heart failure as determined by International Classification of Diseases-10 diagnosis code for heart failure.
• Research opt-out patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Successful detection of asymptomatic LVSD by AI-ECG	During study visit approximately 50 minutes	Device feasibility of AI-ECG will be evaluated by comparing the proportion of patients with LVSD on echocardiography among those with a high predicted probability of LVSD on an AI-ECG screen compared with the proportion of patients with LVSD on echocardiography in those with a negative AI-ECG screen. Higher proportions indicate successful detection of asymptomatic LVSD compared with routine clinical care.

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States