A Study of Artificial Intelligence for Detection of High Potassium Levels in the Emergency Department Using Multilead ECG Devices
Overview
Tab Title Description
Study type
ObservationalDescribes 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: 19-000648
Sponsor Protocol Number: 19-000648
About this study
The primary purpose of this study is to explore KardiaK performance in a controlled and comprehensive clinical setting, including collection of relevant data such as patient medical history, and medications affecting potassium. In addition, it is intended to explore KardiaK performance when serial ECGs are recorded and to explore KardiaK performance using a 12-lead ECG and two novel ECG recording devices designed for home use.
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, age 18 years of age and older.
- Current evaluation with suspected or known hyperkalemia in the setting of kidney disease.
Note: For the sake of this pilot study, and for ease of recruitment, eGFR is not an exclusion criteria. KardiaK was trained and tested on ECGs from patients regardless of eGFR level, so we have no reason to believe the algorithm will not perform well on patients with preserved renal function.
Exclusion Criteria:
- No history of left bundle branch block (LBBB).
- No current evaluation for acute coronary syndrome, where ST segment changes and T wave inversions may occur and therefore affect interpretability of ECG.
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 Paul Friedman, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available