What side effects are associated with this type of intervention?

Common treatments for heart attack include medications like antiplatelets, beta-blockers, ACE inhibitors, and statins, which can cause side effects such as bleeding, bradycardia, hypotension, cough, and muscle pain. Transcutaneous vagus nerve stimulation (tVNS), a treatment being studied for its potential to reduce cardiac arrhythmias by modulating the autonomic nervous system, has been associated with mild side effects such as a warm sensation, numbness, redness, itching, tingling, muscle spasm, and localized pain. There are no serious adverse events reported with tVNS.

What other types of research exist?

Promising, novel alternatives to Transcutaneous Vagus Nerve Stimulation for heart attack patients in 2024 may include remote electrical neuromodulation and spinal cord stimulation. These techniques have shown efficacy in other conditions and could potentially be adapted for reducing cardiac arrhythmias. Additionally, advancements in pharmacologic treatments and cardiac devices should be considered.

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Device

Nerve Stimulation Therapy for Rapid Heartbeat after Heart Attack (EARLY-VAGUS Trial)

Q: What prior FDA approvals exist?

The FDA has approved various treatments for heart attacks, primarily focusing on medications like beta-blockers, ACE inhibitors, and antiplatelet agents to manage symptoms and prevent further cardiac events. In terms of treatments similar to Transcutaneous Vagus Nerve Stimulation (tVNS), which modulates the autonomic nervous system to reduce cardiac arrhythmias, there is limited specific information on FDA approvals. However, neuromodulation techniques, including vagus nerve stimulation, have been explored for their potential benefits in reducing arrhythmias post-myocardial infarction, indicating a growing interest in this therapeutic approach.

N/A

Waitlist Available

Research Sponsored by Hippocration General Hospital

Eligibility Criteria Checklist

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

Must have

ST-elevation myocardial infarction which is treated with a primary percutaneous coronary intervention

Be older than 18 years old

Must not have

Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)

Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 7 and 40 days follow-up

Summary

This trial tests if using a device that sends gentle electrical pulses to a nerve can help patients who had a heart attack by reducing extra heartbeats.

Who is the study for?

This trial is for men and women over 18 who've had a recent heart attack treated with an artery-opening procedure. They must agree to the study rules and follow-up schedule. It's not for those with recent heart procedures, on certain heart drugs, thyroid or severe kidney issues, very short life expectancy, listed for a heart transplant, unstable angina despite treatment, worst class of heart failure, in cardiogenic shock, pregnant women or those with specific genetic heart conditions.

What is being tested?

The trial tests if a non-invasive device called Parasym can prevent rapid heartbeat after a major heart attack by stimulating the vagus nerve through the skin. Participants are randomly assigned to use either an active device that delivers current below discomfort level or a sham (fake) device without current. The study will last about 12 months across two centers in Greece.

What are the potential side effects?

Since this involves non-invasive stimulation at levels below discomfort thresholds using the Parasym device, side effects may be minimal but could include local irritation where the device contacts skin and potential temporary changes in heartbeat patterns.

Eligibility Criteria

Inclusion Criteria

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

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I had a severe heart attack treated with a procedure to open my heart's arteries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant.

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I have a diagnosed heart rhythm disorder.

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I have experienced a severe failure of my heart to pump blood.

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I have severe heart failure that doesn't improve with medication.

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I have had fainting spells more than once.

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I was born with a complex heart condition.

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I have ongoing chest pain despite having heart surgery and taking medication.

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I am currently taking amiodarone.

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I have thyroid problems and am on kidney dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 7 and 40 days follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 7 and 40 days follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 7 and 40 days follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change of Ventricular tachycardia burden

Secondary study objectives

Change of Deceleration Capacity (DC)

Change of Echocardiographic strain

Change of Heart Rate Turbulence

+7 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Transcutaneous Vagal Nerve StimulationActive Control1 Intervention

Group II: Sham Transcutaneous Vagal Nerve StimulationPlacebo Group1 Intervention

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart attacks include medications like beta-blockers, ACE inhibitors, and antiplatelet agents, which work by reducing heart workload, preventing blood clots, and improving blood flow. Additionally, interventions such as percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) restore blood flow to the heart. Treatments like transcutaneous vagus nerve stimulation (tVNS) modulate the autonomic nervous system to reduce cardiac arrhythmias by enhancing parasympathetic activity and reducing sympathetic overdrive, which can stabilize heart rhythms and reduce the risk of further cardiac events. These mechanisms are crucial for heart attack patients as they help to prevent complications, improve heart function, and enhance overall survival.

Reduction of sympathetic inotropic response after ischemia in dogs. Contributor to stunned myocardium.Effects of vagal stimulation on regional myocardial flows and ischemic injury in dogs.[Spinal cord stimulation in severe angina pectoris. Reduced ischemia and increased quality of life].