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Completed

NCT Number: NCT05441852

A Study to Detect Hyperkalemia Using Smartphone-enabled Electrocardiogram (EKG)

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 .

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Key information

Age range

50 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

  • Ambulatory adult patients in the Emergency Department (ED) at increased risk for hyperkalemia (due to age ≥ 50 years, and one or more criteria including estimated Glomerular filtration rate (eGFR) (from serum creatinine) < 45 ml/minute and/or a history of serum potassium > 5.2 milliequivalents per liter (mEq/l) who present to the emergency department will be approached to consent for the rapid screening process.
  • Those who consent will undergo 30 second 6 L ECG recording with a portable, mobile-enhanced device (AliveCor Kardia).
  • This ECG data is subsequently evaluated by our artificial intelligence algorithm to detect hyperkalemia, and the estimated probability of hyperkalemia is recorded.
  • The research team notifies supervising Emergency Department staff of patients whose probability of hyperkalemia is significantly elevated above the optimized cutoff point according to the AI-ECG algorithm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater than/equal to 50 years and able to provide consent.
  • Patients with eGFR (from serum creatinine) < 45 ml/minute and/or a history of serum potassium > 5.2 mEq/l.

Exclusion criteria

  • Patients underage < 50.
  • Do not meet inclusion criteria.
  • Unstable patients requiring emergent resuscitation.
  • Patients unable to provide consent.

Treatment and study plan

Primary outcomes

  1. Hyperkalemia detection by AI enhanced ECG

    Time frame: 12 months

    Understanding model's ability to predict hyperkalemia as determined by the area under the receiver operating characteristic

Secondary outcomes

  1. Performance metrics for the detection of hyperkalemia by AI enhanced ECG

    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.

Other outcomes

  1. Time to laboratory confirmed hyperkalemia diagnosis

    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.

  2. Time to first treatment of hyperkalemia in Emergency Department

    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.

  3. Total time spent in 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.

  4. Hospital Admission Rate for Hyperkalemia patients

    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.

  5. One year survival for hyperkalemic patients

    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.

  6. Rate of Adverse Events related to hyperkalemia

    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).

  7. Exploratory AI enhanced ECG analysis for heart failure

    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.

  8. Exploratory AI enhanced ECG analysis for silent/paroxysmal atrial fibrillation

    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.

  9. Exploratory AI enhanced ECG analysis for aortic stenosis

    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.

  10. Exploratory AI enhanced ECG analysis for amyloidosis

    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.

  11. Exploratory AI enhanced ECG analysis to determine age

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Rapid dEtection of HyperkAlemia (K+) in the EmergenCy Department Using a SmarTphone-enabled Single-lead EKG (REACT)

Acronym: REACT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 1, 2022
Registry last updated
Jul 14, 2023

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.

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