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AI-ECG for Left Ventricular Dysfunction
N/A
Recruiting
Led By Rohan Khera, MD, MS
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during study visit approximately 50 minutes
Awards & highlights
Study Summary
This trial aims to test a smartphone tool to detect heart problems, like LVSD, in everyday life.
Who is the study for?
This trial is for individuals who can give informed consent and are willing to follow the study procedures. It's not for those with a known heart failure diagnosis, prior low ejection fraction (EF), or previous echocardiograms, nor for patients with an intermediate chance of low EF.Check my eligibility
What is being tested?
The SMART-LV Pilot Study is testing an AI-powered electrocardiogram (AI-ECG) that works with smartphones to predict and detect left ventricular systolic dysfunction in real-world conditions.See study design
What are the potential side effects?
Since this study involves non-invasive AI-ECG monitoring, there are minimal expected side effects. However, some participants might experience discomfort or anxiety during ECG recording.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during study visit approximately 50 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during study visit approximately 50 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful detection of asymptomatic LVSD by AI-ECG
Trial Design
1Treatment groups
Experimental Treatment
Group I: AI-ECGExperimental Treatment1 Intervention
A novel AI-ECG model developed at the Cardiovascular Data Science (CarDS) lab will be used as Software as Medical Device (SaMD) on ECG images for detection of LVSD.The AI-ECG model will be used on all participants undergoing a 12-lead ECG.
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,728,393 Total Patients Enrolled
Rohan Khera, MD, MSPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a chance of having a weak heart function (10 to 80%).
Research Study Groups:
This trial has the following groups:- Group 1: AI-ECG
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently accepting new participants for this experiment?
"Currently, this clinical trial is not seeking any more participants as evidenced by the information on clinicaltrials.gov; which was first posted on December 1st 2022 and last edited November 29th 2022. Despite that, there are 46 other research studies actively recruiting at this time."
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