Other Clinical Trial - The SMART-LV Pilot Study

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Left Ventricular Systolic Dysfunction
Systolic Murmurs
Ventricular Dysfunction, Left

Clinical Trial Details

NCT number	NCT05630170
Study type	Interventional
Source	Yale University
Contact
Status	Completed
Phase	N/A
Start date	September 13, 2023
Completion date	May 22, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT01058837` - SCD-HeFT 10 Year Follow-up	N/A
Completed	`NCT00752752` - The Acute Cardiovascular Effects of Marathon Running Using Magnetic Resonance Imaging	N/A
Recruiting	`NCT04166331` - Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion	Phase 3
Active, not recruiting	`NCT05764109` - Adherence to Cied Implantation Guidelines and Cardiac Rehabilitation
Terminated	`NCT01969890` - STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial	Phase 3
Recruiting	`NCT01747187` - Cardiac Stress in Septic Shock - Biomarkers, Echocardiography and Outcome	N/A
Completed	`NCT01162083` - Identifying an Ideal Cardiopulmonary Exercise Test Parameter	N/A
Completed	`NCT04221763` - Mechanisms and Innovations in Cardiac Resynchronisation Therapy	N/A
Recruiting	`NCT06221891` - Early Evaluation of Left Ventricular Systolic Function Impairment in Patients With Chronic Kidney Disease by Multimodal Ultrasonography
Completed	`NCT04231331` - Ertugliflozin for Functional Mitral Regurgitation	Phase 3
Completed	`NCT01500759` - Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry
Recruiting	`NCT05714085` - Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)	Phase 2/Phase 3
Completed	`NCT01086124` - Objective Systolic Function Recuperation Assessed by Echocardiography	N/A
Recruiting	`NCT06270498` - Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure	Phase 4
Completed	`NCT03470155` - Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function
Suspended	`NCT03755570` - How is COGNItive Function Affected by Cardiac Resynchronisation Therapy?
Recruiting	`NCT04399447` - Multicenter Normal Reference Study of Tissue Motion Tracking of Mitral Annular Displacement(TMAD)
Not yet recruiting	`NCT03993730` - Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy	N/A
Active, not recruiting	`NCT01918215` - Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction.	N/A
Completed	`NCT02851745` - Effects of Linagliptin on Left Ventricular Myocardial DYsfunction in Patients With Type 2 DiAbetes Mellitus and Concentric Left Ventricular Geometry	Phase 3