1000 Participants NeededMy employer runs this trial

Smartphone ECG for Heart Attack

(STLEUISII Trial)

Recruiting at 3 trial locations
CR
KR
Overseen ByKimberly Roohi, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: AliveCor
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device called the AliveCor 12-lead ECG. The device helps diagnose heart attacks, such as STEMI and NSTEMI, as effectively as current standard equipment. The trial focuses on comparing its accuracy to existing 12-lead ECG machines in emergency settings. Individuals experiencing chest pain and visiting the emergency department may qualify for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance heart attack diagnosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ECG device is safe for diagnosing heart attacks?

Studies have shown that the AliveCor 12-lead ECG System performs as effectively as standard 12-lead ECG machines. It safely and accurately records heart signals. Healthcare settings have used the device to detect various heart conditions, including heart attacks. Tests with earlier versions demonstrated that the device functioned well without causing patient issues. It quickly identifies serious heart problems, aiding in timely care. With FDA clearance for similar uses, the device is generally considered safe for use.12345

Why are researchers excited about this trial?

Most treatments for heart attacks involve medications like aspirin, beta-blockers, and nitrates, as well as procedures such as angioplasty. However, the AliveCor 12-lead ECG is unique because it offers a portable, smartphone-based method to quickly assess heart health. This innovation allows for real-time monitoring outside traditional medical settings, which could lead to faster diagnosis and treatment. Researchers are excited about this technology as it has the potential to improve accessibility and convenience, enabling earlier intervention and possibly better outcomes for patients experiencing heart attacks.

What evidence suggests that the AliveCor 12-lead ECG is effective for diagnosing heart attacks?

Research has shown that the AliveCor 12-lead ECG system, which participants in this trial will use, effectively diagnoses heart attacks, including STEMI and NSTEMI types. A previous study confirmed the device's accuracy by comparing it to standard 12-lead ECGs, finding similar results in most cases. The system quickly and accurately checks heart rhythms, making it a valuable tool in emergencies. Additionally, the device records an ECG faster than traditional methods. Overall, the AliveCor 12-lead ECG has proven its ability to effectively detect various heart problems.16789

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
I am over 18 years old.
I experienced chest pain when I arrived at the emergency room.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

ECG Procedure

Participants undergo a single research-related procedure using the AliveCor 12-lead ECG system

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ECG procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AliveCor 12-lead ECG

Trial Overview

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.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: AliveCor 12-lead ECGExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AliveCor

Lead Sponsor

Trials
5
Recruited
1,300+

Citations

New Study Shows AliveCor's Kardia 12L ECG System ...

The pocket-sized Kardia 12L ECG System was designed exclusively for healthcare settings to detect 35 cardiac determinations, including heart attack.

Efficiency of an artificial intelligence-aided portable 12-lead ...

In this study, utilization of Kardia 12L significantly reduced ECG acquisition time compared with standard 12-lead ECGs (7.1 minute vs 10.0 ...

Abstract 11623: Determination of the Diagnostic Accuracy ...

Qualitative, interpretable paired ECG evaluations showed 152 (79.2%), 32 (16.7%) and 8 (4.2%) pairs with good, fair and poor correlation, ...

Phone app effectively identifies potentially fatal heart ...

A typical ECG has 12 leads, which improves the accuracy of a diagnosis because heart attacks happen in different parts of the heart, and each ...

Kardia Mobile applicability in clinical practice: A comparison of ...

KM was superior in detection of sinus rhythm than eye-ball evaluation of 12-lead ECG. Though, the PQ and QT intervals were shorter in KM as compared to 12-lead ...

Kardia 12L

Kardia 12L is an AI-powered handheld 12-lead resting ECG system. With simplified leadset technology, Kardia 12L offers outstanding clinical efficiency.

Smartphone Twelve-Lead ECG Utility In ST-Elevation ...

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 ...

Smartphone ECG for evaluation of ST-segment elevation ...

A newer prototype has been developed as a smartphone ECG system that has the potential to provide all 12–lead recordings of a standard 12–lead ECG system.

AliveCor's Mobile ECG Technology Could Enable More ...

A research version of its mobile technology can identify ST-elevation myocardial infarction (STEMI), the most severe form of heart attack.