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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.

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
NameTimeMethod
Successful detection of asymptomatic LVSD by AI-ECGDuring 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Yale New Haven Hospital

🇺🇸

New Haven, Connecticut, United States

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

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