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Procedure

AliveCor 12-lead ECG for Cardiovascular Disease (STLEUISII Trial)

N/A

Recruiting

Research Sponsored by AliveCor

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptoms of chest pain upon presentation at the Emergency Department of the participating institution

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 seconds

Awards & highlights

STLEUISII Trial Summary

This trial is testing a new device called AliveCor (AC) 12-lead (12L) ECG System that can record 4 leads of ECG at the same time and generate a

Who is the study for?

This trial is for adults over 18 who can consent to participate and are experiencing chest pain upon arrival at the Emergency Department. It's designed for those with various heart conditions, including heart failure, myocardial infarction (heart attack), and other related cardiovascular diseases.Check my eligibility

What is being tested?

The trial is testing the AliveCor 12-lead ECG System, a new device that works with smartphones to record ECGs. The goal is to see if it can diagnose serious heart attacks (STEMI and NSTEMI) as accurately as standard ECG devices in hospitals.See study design

What are the potential side effects?

Since this study involves non-invasive ECG monitoring using a smartphone-compatible device, there are no direct side effects from the intervention itself. However, participants may experience discomfort or anxiety during the ECG recording.

STLEUISII Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I experienced chest pain when I arrived at the emergency room.

STLEUISII Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 seconds

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 seconds

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 seconds for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Inter-rater variability for AC 12L ECG readings

Inter-rater variability for Standard 12-lead ECG readings

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

+8 more

STLEUISII Trial Design

1Treatment groups

Experimental Treatment

Group I: AliveCor 12-lead ECGExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

AliveCorLead Sponsor

4 Previous Clinical Trials

310 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this study?

"As per the information available on clinicaltrials.gov, recruitment for this specific trial is presently closed. The trial was first listed on 2/1/2024 and last updated on 2/26/2024. While this study currently isn't enrolling participants, there are a total of 2322 other ongoing studies actively seeking candidates for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II

2024. "Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06271577.

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