A Multicenter Pragmatic Implementation Study of AI-ECG-Based Clinical Decision Support Software to Identify Low LVEF

Overview

About this study

The purpose of this stuyd is to evaluate the impact of an ECG-based artificial intelligence (AI-ECG) algorithm to detect low left ventricular ejection fraction (LVEF) on diagnosis rates of LVEF ≤ 40% in the outpatient setting, to evaluate the impacts of an AI-ECG algorithm to detect low LVEF and an associated clinical decision support software when used during routine outpatient care. The study will be conducted in 2 phases: feasibility assessment phase and clinical impact phase.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Adults 18 years or older

- Digital 10 second, 12 Lead ECG captured or available in EHR or ECG data store for
AI-ECG analysis at point-of-care

Exclusion Criteria:

- Known history of LVEF ≤ 40%

- Known history of heart failure

- Opted out of electronic health record-based research

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/13/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Rushlow, M.D.

Open for enrollment

Contact information:

Julie Maxson CCRP

(507) 266-0284

maxson.julie@mayo.edu

More information

Publications

Publications are currently not available