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

Overview

About this study

The purpose of this study is to evaluate the impacts of an ECG-AI algorithm to detect low left ventricular ejection fraction (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:

- Males and females 18 years or older (including females who are pregnant, breastfeeding
and/or lactating)

- Digital ECG captured or available within site for ECG-AI analysis at point-of-care

Exclusion Criteria:

- Known history of LVEF ≤ 40%

- Known history of systolic heart failure

- Known history of heart failure with reduced ejection fraction

- Opted out of electronic health record-based research

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

Eligibility last updated 2/23/2024. 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
Jacksonville, Fla. Mayo Clinic principal investigator Anja Kinaszczuk, D.O.	Open for enrollment	Contact information: Clinical Studies Unit (904) 953-2255

Mayo Clinic Location

Status

Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Anja Kinaszczuk, D.O.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available

Clinical Trials