Brief Summary
This is a multi-site, retrospective study to evaluate the performance of a locked AI-based algorithm for detection of left ventricular systolic dysfunction. A prerequisite for inclusion of subjects from each institution will be the availability of at least one digital 12-lead ECG paired with an echocardiogram with LVEF information within 30 days of the date of the ECG. The AI-ECG LVSD algorithm will be applied on all ECGs and diagnostic performance features for the detection of LVSD will be estimated using the provided paired LVEF value (Low LVEF as the reference label). Performance will also be assessed in subgroups of subjects determined by demographic and clinical factors.
Brief Title
A Multi-Center Study of Detection of Low Ventricular Ejection Fraction
Detailed Description
Following institutional review board approval, 12,000 12-lead ECG's paired with an echocardiogram with LVEF information within 30 days of the date of the ECG will be collected across three enrolled sites. Each site will provide data from up to 4000 enrolled subjects that meet the inclusion criteria. No other demographic characteristics or enrichment will be considered in the selection of subjects in order to best represent the general population for that site. Sites will securely transfer the data to a centralized repository for processing.
Once data is collected, the device will be used to analyze the ECG data for all enrolled subjects without reference or access to the echocardiogram data. The device will display a binary 36 prediction of the likelihood of LVEF less than or equal to 40%. Results will be compared to the echocardiogram reference standard in accordance with the statistical analysis plan.
Once data is collected, the device will be used to analyze the ECG data for all enrolled subjects without reference or access to the echocardiogram data. The device will display a binary 36 prediction of the likelihood of LVEF less than or equal to 40%. Results will be compared to the echocardiogram reference standard in accordance with the statistical analysis plan.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Cardiac Disease
Eligibility Criteria
Inclusion Criteria:
- Adult subjects with or without known cardiac disease who are either inpatients or outpatients with ECGs and an echocardiogram within 30-days of the ECG date.
Exclusion Criteria:
* No research authorization provided
* An ECG signal shorter than 10 seconds or that is not interpretable
* An echocardiogram is considered technically challenging
* Only qualitative interpretation of left ventricular systolic function available (i.e., "decreased EF") without a numerical value.
* A paced rhythm
- Adult subjects with or without known cardiac disease who are either inpatients or outpatients with ECGs and an echocardiogram within 30-days of the ECG date.
Exclusion Criteria:
* No research authorization provided
* An ECG signal shorter than 10 seconds or that is not interpretable
* An echocardiogram is considered technically challenging
* Only qualitative interpretation of left ventricular systolic function available (i.e., "decreased EF") without a numerical value.
* A paced rhythm
Inclusion Criteria
Inclusion Criteria:
- Adult subjects with or without known cardiac disease who are either inpatients or outpatients with ECGs and an echocardiogram within 30-days of the ECG date.
- Adult subjects with or without known cardiac disease who are either inpatients or outpatients with ECGs and an echocardiogram within 30-days of the ECG date.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT04963218
Org Class
Other
Org Full Name
Mayo Clinic
Org Study Id
21-003530
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Multicenter Study of Detection of Low Ventricular Ejection Fraction (LVEF) ≤ 40% Based on Point-of-Care 12- Lead ECG Data
Primary Outcomes
Outcome Description
Number of participants with presence of EF less than of equal to 40% identified by 12-lead AI ECG algorithm
Outcome Measure
Established Diagnostic Performance
Outcome Time Frame
1 month
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Adult subjects with or without known cardiac disease who are either inpatients or outpatients with ECGs and an echocardiogram within 30-days of the ECG date.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Andrew Krumerman
Investigator Email
akrumerm@montefiore.org
Investigator Phone