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

NCT04963218 | Completed

• 1 other identifier: 21-003530
• Study Type: observational
• Target: 16,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• Established Diagnostic Performance

  Number of participants with presence of EF less than of equal to 40% identified by 12-lead AI ECG algorithm

  1 month

Interventions

AI Algorithm to detect LVEF in ECG DIAGNOSTIC_TEST

A clinical decision support software as a medical device that detects whether a patient has LVEF less than or equal to 40% based upon the input of one or more ECG vectors at the point-of-care.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

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

Sponsors & Collaborators

• Mayo Clinic: lead
• Anumana, Inc.: collaborator

Study Sites (4)

Beth Israel Deacon Medical Center

Boston, Massachusetts, 02215, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Monument Health

Rapid City, South Dakota, 57701, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Diseases

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Peter Noseworthy, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 15, 2021
• Study Start: August 30, 2021
• Primary Completion: April 13, 2022
• Study Completion: April 13, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)