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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04963218
Recruitment Status : Completed
First Posted : July 15, 2021
Last Update Posted : July 13, 2022
Sponsor:
Collaborator:
Anumana, Inc.
Information provided by (Responsible Party):
Peter A. Noseworthy, M.D., Mayo Clinic

Tracking Information
First Submitted Date July 1, 2021
First Posted Date July 15, 2021
Last Update Posted Date July 13, 2022
Actual Study Start Date August 30, 2021
Actual Primary Completion Date April 13, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2021)
Established Diagnostic Performance [ Time Frame: 1 month ]
Number of participants with presence of EF less than of equal to 40% identified by 12-lead AI ECG algorithm
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Multi-Center Study of Detection of Low Ventricular Ejection Fraction
Official Title A Multicenter Study of Detection of Low Ventricular Ejection Fraction (LVEF) ≤ 40% Based on Point-of-Care 12- Lead ECG Data
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Cardiac Disease
Intervention Diagnostic Test: AI Algorithm to detect LVEF in ECG
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 11, 2022)
16000
Original Estimated Enrollment
 (submitted: July 14, 2021)
12000
Actual Study Completion Date April 13, 2022
Actual Primary Completion Date April 13, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04963218
Other Study ID Numbers 21-003530
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Peter A. Noseworthy, M.D., Mayo Clinic
Original Responsible Party Same as current
Current Study Sponsor Mayo Clinic
Original Study Sponsor Same as current
Collaborators Anumana, Inc.
Investigators
Principal Investigator: Peter Noseworthy, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date July 2022