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

NCT05441852 | Completed

• 1 other identifier: 21-006298
• Study Type: observational
• Target: 1,151
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Hyperkalemia

Keywords

electrocardiogram (ECG); Artificial Intelligence (AI); neural network; hyperkalemia; Emergency Department (ED); Smartphone; AliveCor Kardia 6 L ECG device

Outcome Measures

Primary Outcomes (1)

• Hyperkalemia detection by AI enhanced ECG

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

  12 months

Secondary Outcomes (1)

• Performance metrics for the detection of hyperkalemia by AI enhanced ECG

  12 months

Other Outcomes (11)

• Time to laboratory confirmed hyperkalemia diagnosis

  12 months

• Time to first treatment of hyperkalemia in Emergency Department

  12 months

• Total time spent in Emergency Department

  12 Months

Study Arms (1)

Ambulatory Emergency Department Patients at risk for hyperkalemia

Patients who are at elevated risk for hyperkalemia identified during a visit to the emergency department. Elevated risk individuals are defined in this study as: \>50 years of age, eGFR \<45, or prior K \>5.2

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in the emergency department who meet the above inclusion criteria. Patients with the above inclusion criteria experience hyperkalemia more frequently than the general population at a prevalence near 10% compared to 2-4%, respectively.

You may qualify if:

• 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.

You may not qualify if:

• Patients underage \< 50.
• Unstable patients requiring emergent resuscitation.
• Patients unable to provide consent.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hyperkalemia; Emergencies

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Dillon, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: July 1, 2022
• Study Start: March 31, 2022
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)