Mayo Clinic
Rochester, Minnesota, 55905, United States
NCT Number: NCT05441852
The purpose of this study is to validate the real-world performance of a previously developed Artificial Intelligence - Electrocardiogram (AI-ECG) algorithm for identification of hyperkalemia with a six-lead mobile-enhanced device .
Looking for future studies?
Notify Me50 year–89 year
All sexes
Observational
Rochester, Minnesota, 55905, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 months
Understanding model's ability to predict hyperkalemia as determined by the area under the receiver operating characteristic
Time frame: 12 months
Detailed performance metrics of the algorithm (sensitivity, specificity, positive predictive value and negative predictive value) will be calculated using an optimized cutoff threshold determined from the primary outcome.
Time frame: 12 months
Following the detection of hyperkalemia by AI enhanced ECG time to initial hyperkalemia diagnosis (in minutes) by laboratory analysis following ambulatory emergency department presentation will be assessed.
Time frame: 12 months
Following outcome measure 3 for patients determined to have hyperkalemia, time to first treatment intervention of hyperkalemia (in minutes) will be assessed since presentation to the emergency department.
Time frame: 12 Months
Patients who underwent AI enhanced screening for hyperkaliemia, and have a diagnosis of hyperkalemia by laboratory confirmation, will also be assessed for total time spent in the emergency department in hours.
Time frame: 12 months
Patients who underwent AI enhanced screening for hyperkaliemia, and have a diagnosis of hyperkalemia by laboratory confirmation, will have the frequency of hospital admission assessed.
Time frame: 12 months
Patients who underwent AI enhanced screening for hyperkaliemia, and have a diagnosis of hyperkalemia by laboratory confirmation, will have evaluation of survival at one year.
Time frame: 12 months
Patients who underwent AI enhanced screening for hyperkaliemia, and have a diagnosis of hyperkalemia by laboratory confirmation, will have evaluation of frequency of adverse events related to treatment of hyperkalemia (cardiac arrest, hypoglycemia, complications related to dialysis etc).
Time frame: 12 months
A previously developed AI algorithm to predict potential underlying cardiac pathology assess from 12 lead ECG via convolutional neural network will be adapted applied to the ECGs for patients who undergo screening for hyperkaliemia in the ED with 6L Kardia ECG device. This neural network uses PQRST complexes to yield a probability of heart failure which may not be readily apparent via manual review. Each recorded 6L Kardia ECG will undergo evaluation by this neural network and will produce a probability of heart failure (0-100%) for each individual patient.
Time frame: 12 months
A previously developed AI algorithm to predict potential underlying cardiac pathology assess from 12 lead ECG via convolutional neural network will be adapted applied to the ECGs for patients who undergo screening for hyperkaliemia in the ED with 6L Kardia ECG device. This neural network uses PQRST complexes to yield a probability of silent/paroxysmal atrial fibrillation which may not be readily apparent via manual review. Each recorded 6L Kardia ECG will undergo evaluation by this neural network and will produce a probability of silent/paroxysmal atrial fibrillation (0-100%) for each individual patient.
Time frame: 12 months
A previously developed AI algorithm to predict potential underlying cardiac pathology assess from 12 lead ECG via convolutional neural network will be adapted applied to the ECGs for patients who undergo screening for hyperkaliemia in the ED with 6L Kardia ECG device. This neural network uses PQRST complexes to yield a probability of aortic stenosis which may not be readily apparent via manual review. Each recorded 6L Kardia ECG will undergo evaluation by this neural network and will produce a probability of aortic stenosis (0-100%) for each individual patient.
Time frame: 12 months
A previously developed AI algorithm to predict potential underlying cardiac pathology assess from 12 lead ECG via convolutional neural network will be adapted applied to the ECGs for patients who undergo screening for hyperkaliemia in the ED with 6L Kardia ECG device. This neural network uses PQRST complexes to yield a probability of amyloidosis which may not be readily apparent via manual review. Each recorded 6L Kardia ECG will undergo evaluation by this neural network and will produce a probability of amyloidosis (0-100%) for each individual patient.
Time frame: 12 months
A previously developed AI algorithm to predict patient age from 12 lead ECG via convolutional neural network will be adapted applied to the ECGs for patients who undergo screening for hyperkaliemia in the ED with 6L Kardia ECG device. This neural network uses PQRST complexes to yield an ECG-predicted age. Each recorded 6L Kardia ECG will undergo evaluation by this neural network and determine "ECG age" for each individual patient.
Mayo Clinic
Other
Rapid dEtection of HyperkAlemia (K+) in the EmergenCy Department Using a SmarTphone-enabled Single-lead EKG (REACT)
Acronym: REACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04012138
Glucose Metabolism Disorders, Hyperinsulinism
Agen, France
View Trial DetailsNCT05004363
ACE Inhibitor Induced Hyperkalaemia, Acute Kidney Injury
London, United Kingdom
View Trial DetailsNCT05136664
Chronic Disease, Disease Attributes
Hefei, Anhui, China
View Trial DetailsNCT07054905
Chronic Disease, Chronic Kidney Disease
Daejeon, South Korea
View Trial Details