Effects of Early Vagus Nerve Stimulation on Infarct Damage and Functioning After Acute STEMI

Summary

The goal of this clinical trial is to investigate whether early non-invasive vagus nerve stimulation (nVNS) can reduce infarct damage and improve functioning after acute ST-elevation myocardial infarction (STEMI). It will assess the safety and effectiveness of nVNS in improving cardiac outcomes. The main questions it aims to answer are:

* Does nVNS improve short-term prognosis post-STEMI by enhancing heart rate variability (HRV) and reducing inflammation?
* Does nVNS reduce infarct size, improve left ventricular function, and lower inflammatory markers compared to sham stimulation?

Participants will be randomly assigned to one of two groups:

* Experimental group: Receive standard care plus nVNS for 60 minutes at the right ear using the Parasym device under ECG monitoring.
* Control group: Receive standard care plus sham nVNS (placebo-like procedure without stimulation).

Participants will undergo stimulation once for 60 minutes post-percutaneous coronary intervention (PCI), and be monitored for adverse reactions like bradycardia, with immediate cessation if needed.

Key study details:

* Inclusion criteria: Adults aged 25-75 years with confirmed STEMI (clinical signs and elevated troponin).
* Exclusion criteria: Bradycardia (HR \< 50 bpm), extensive anterior MI, hypotension, or severe cardiac/medical conditions.
* Intervention parameters: Stimulation targeting the auricular branch of the vagal nerve with 200µs pulse width, 20Hz frequency, and adjustable intensity (10-50mA), remaining below the pain threshold.

Outcomes measured:

* Primary outcomes: Wall motion score index (WMSI) and left ventricular ejection fraction (LVEF).
* Secondary outcomes: HRV metrics, troponin levels, inflammatory markers (CRP, NLR), atrial fibrillation events, hospitalization duration, one-month survival, quality of life (HeartQOL scale), and one-year survival.

Statistical analysis: Researchers will compare baseline characteristics using t-tests and chi-square tests. Main analyses will involve repeated measures mixed-design ANOVA and multivariate ANOVA. Moderation analysis will assess the influence of the experimental condition on inflammation and clinical outcomes.

Ethical considerations: The study complies with Israeli Ministry of Health guidelines for emergency clinical trials. Participants will provide verbal consent followed by written consent. Ethical approval was granted by the IRB of Bnai Zion Medical Center, Haifa, Israel (Approval No. 0169-21-BNZ).

Conditions

• ST Elevation Myocardial Infarction (STEMI)

Interventions

DEVICE

Active noninvasive vagus nerve stimulation

The stimulation parameters include a 200µs stimulation width, at an intensity level of 10-50ma (adjusted for patient-comfort), at a frequency of 20Hz during 60min .

OTHER

Chum electrode attached to patient's lower ear lobe

The clip stimulator is attached to the patient's lower ear lobe without stimulation.

Sponsors & Collaborators

• University of Haifa

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• Bnai Zion Medical Center

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-01

Primary Completion

2025-01-05

Completion

2025-12-30

Countries

• Israel

Study Locations