A Multicenter Pragmatic Implementation Study of AI-ECG-Based Clinical Decision Support Software to Identify Low LVEF
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-008513
NCT ID: NCT05867407
Sponsor Protocol Number: DOC-244
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator David Rushlow, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available