NCT06271577

Brief Summary

AliveCor (www.alivecor.com) has developed several electrocardiogram (ECG) devices that interface with iOS and Android smartphones and tablets via various Kardia apps. The current Kardia family of devices can measure single lead and six limb-lead ECGs, depending on the device. KardiaMobile, KardiaMobile 6L, and KardiaMobile Card have FDA clearance for ECG rhythm recording. A modified single-lead Kardia smartphone 12-lead ECG was previously validated in the multicenter ST LEUIS study for the diagnosis of ST-Segment Elevation Myocardial Infarction (STEMI) and Non-ST-Elevation Myocardial Infarction (NSTEMI). Recently, AliveCor developed a new device: AliveCor (AC) 12-lead (12L) ECG System to record simultaneously 4 leads of ECG and then generate complete 12-lead ECGs. A previous protocol at the University of Oklahoma involved 200 subjects with early prototypes of the AC 12L device with the specific aim to validate that it accurately generated 12-lead ECGs as compared to simultaneously acquired FDA-cleared 12-lead ECGs. The prototype version of the AliveCor 12L ECG System simultaneously measured four channels of ECG (leads I, II, V2, V4), calculated the remaining limb leads as is standard for 12-lead ECGs (Leads III, aVR, aVL, aVF) and synthesized the remaining 4 precordial ECG leads (V1, V3, V5, V6). This protocol will serve to validate the production version of the system against standard 12-Lead ECGs for the diagnosis of STEMI and NSTEMI in patients admitted to the Emergency Department or directly to the Cardiac Cath Lab for the evaluation of chest pain. It is anticipated that the waveforms for each of the 12 leads from the AC 12L ECG System will be highly correlated with the corresponding leads from the comparator commercially available 12-lead ECG devices used at participating sites. The purpose of this study is to clinically validate that the four-channel AC 12L ECG device can enable the diagnosis of STEMI and NSTEMI in a non-inferior manner to existing 12-lead ECG devices.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Mar 2024Mar 2027

First Submitted

Initial submission to the registry

February 12, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

March 12, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

February 12, 2024

Last Update Submit

April 8, 2026

Conditions

Heart DiseasesHeart AttackHeart FailureMyocardial IschemiaCardiovascular DiseasesVascular DiseasesMyocardial InfarctionIschemia

Outcome Measures

Primary Outcomes (11)

  • Inter-rater variability for Standard 12-lead ECG readings

    30 seconds

  • Inter-rater variability for AC 12L ECG readings

    30 seconds

  • Number of standard 12-lead ECG readings requiring a consensus consultation

    30 seconds

  • Number of AC 12L ECG readings requiring a consensus consultation

    30 seconds

  • Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI

    30 seconds

  • Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI

    30 seconds

  • Positive predictive value of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI

    30 seconds

  • Negative predictive power of the AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI

    30 seconds

  • Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI

    30 seconds

  • Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI

    30 seconds

  • Mean summative ST-segment elevation, summative ST-segment depression and summative ST-segment deviation for AC 12L ECGs compared to standard 12-lead ECGs

    30 seconds

Study Arms (1)

AliveCor 12-lead ECG

EXPERIMENTAL

A single research-related procedure will be required (i.e., an AliveCor 12-lead ECG). Effort will be made to ensure that the performance of this procedure will not delay any treatment and/or diagnostic procedures that are part of usual or specialized care that the patient requires.

Device: AliveCor 12-lead ECG

Interventions

AliveCor 12-lead ECGDEVICE

The primary objective of this study is to determine if the AliveCor 12-lead Smartphone ECG is an acceptable substitute for a standard 12-lead ECG in the identification of STEMI and NSTEMI.

AliveCor 12-lead ECG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female \> 18 years of age.
  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
  • Symptoms of chest pain upon presentation at the Emergency Department of the participating institution.

You may not qualify if:

  • Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason.
  • Other conditions that in the opinion of the Lead Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Intermountain Health

Murray, Utah, 84107, United States

RECRUITING

Leeds General Infirmary

Leeds, England, United Kingdom

NOT YET RECRUITING

University of Edinburgh

Edinburgh, Scotland, United Kingdom

NOT YET RECRUITING

Related Publications (1)

  • Muhlestein JB, Anderson JL, Bethea CF, Severance HW, Mentz RJ, Barsness GW, Barbagelata A, Albert D, Le VT, Bunch TJ, Yanowitz F, May HT, Chisum B, Ronnow BS, Muhlestein JB; Duke University Cooperative Cardiovascular Society (DUCCS) investigators. Feasibility of combining serial smartphone single-lead electrocardiograms for the diagnosis of ST-elevation myocardial infarction. Am Heart J. 2020 Mar;221:125-135. doi: 10.1016/j.ahj.2019.12.016. Epub 2019 Dec 27.

    PMID: 31986289BACKGROUND

MeSH Terms

Conditions

Myocardial InfarctionIschemiaMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesHeart Failure

Condition Hierarchy (Ancestors)

InfarctionPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Kimberly Roohi, MS

CONTACT

855-338-8800kroohi730@alivecor.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 22, 2024

Study Start

March 12, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)GB(2)