A Multi-Center Study of Detection of Low Ventricular Ejection Fraction

Completed

Conditions studied: Cardiac Disease

In brief

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.

Key facts

Study ID: NCT04963218
Run by: Mayo Clinic
People needed: 16000
Starts: 2021-08-30
Expected to finish: 2022-04-13
Last updated by the study team: 2022-07-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Beth Israel Deacon Medical Center — Boston, Massachusetts, United States
Montefiore Medical Center — The Bronx, New York, United States
Monument Health — Rapid City, South Dakota, United States
University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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