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NCT Number: NCT06865716

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

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).

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Key information

Conditions

ST Elevation Myocardial Infarction (STEMI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bnai Zion Medical Center, 47 Golomb Street, Cardiology Department Main Building, Haifa, Israel

Haifa, Haifa District, 3104802, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having had an MI verified by clinical signs (e.g., pain in the chest, left arm, left shoulder), ST-elevation MI (STEMI) and clinically significant elevations of troponin values (cut-off value 19 ng/l or using sex-specific cut-off values of 14ng/l for women and 22ng/l for men.
  • Between 25-75 years of age.
  • Patients with Intra-Aortic Balloon.

Exclusion criteria

  • Heart rate (HR) < 50 bpm (bradycardia)
  • Extensive anterior MI: According to infarct size criteria: KILLIP III & KILLIP IV of Heart Failure following MI is defined as Extensive anterior MI.
  • Hypotension (systolic blood pressure < 90mmHg).
  • Sildenafil treatment.
  • Diagnosed with Atrial Fibrillation.
  • Diagnosed with Ventricular arrythmias not including Accelerated Idio Ventricular Rhythm (AIVR).
  • Anaesthetize patient.
  • Mechanical ventilated patient.
  • Participation in another trial

Treatment and study plan

Active noninvasive vagus nerve stimulation

Device

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 .

Chum electrode attached to patient's lower ear lobe

Other

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

Primary outcomes

  1. Wall Motion Score Index

    Time frame: One to 2 days after stimulation: 24-48 hours post-stimulation

    The wall motion score index (WMSI) numerically sums the average scores for all left ventricular segments into a single parameter. The prognostic value of WMSI has been investigated in small cohorts of patients with acute myocardial infarction, suggesting superiority to LVEF in predicting mortality

  2. Left ventricular ejection fraction (LVEF)

    Time frame: One to 2 days after stimulation: 24-48 hours post-stimulation

    LVEF is the fraction of chamber volume ejected in systole (stroke volume) in relation to the volume of the blood in the ventricle at the end of diastole (end-diastolic volume). Stroke volume is calculated as the difference between EDV and end-systolic volume (ESV). This activity reviews the calculation of LVEF, its clinical relevance and highlights the role of the interprofessional team in managing patients with depressed LVEF.

Secondary outcomes

  1. survival

    Time frame: one month after the intervention and one year after

    The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works. Also called OS.

  2. quality of lifeQuality of life will be assessed using the Heart Disease-Specific Quality of Life Questionnaire (HeartQOL).

    Time frame: Data will be collected 24 hours after the intervention and one month after discharge.

    Patients' definitions of QOL included three components: 1) ability to perform physical and social activities, 2) maintaining happiness, and 3) engaging in fulfilling relationships.This scale includes 14 items scored on a 4-point Likert scale (0 = 'Not at all' to 3 = 'Very much'). The total score ranges from 0 to 3, with higher scores indicating worse quality of life and lower scores indicating better quality of life..

  3. inflammatory markers of CRP

    Time frame: Baseline (before intervention), 24 hours post-intervention and 48 hours post-intervention .

    C-reactive protein (CRP) levels will be monitored using routine blood tests collected during hospitalization.

    • Unit of Measure: Milligrams per liter (mg/L).

  4. inflammatory markers of Neutrophil-to-Lymphocyte Ratio (NLR)

    Time frame: Baseline (before intervention), 24 hours post-intervention and 48 hours post-intervention

    Neutrophil-to-lymphocyte ratio (NLR) will be calculated from routine blood tests collected during hospitalization.•Unit of Measure: Ratio (neutrophils to lymphocytes).

  5. Troponin

    Time frame: Baseline (before intervention), 24 hours post-intervention and 48 hours post-intervention

    Troponin levels will be measured using routine blood samples collected during hospitalization. Troponin is a biomarker that rises in cases of myocardial infarction.• Unit of Measure: Nanograms per liter (ng/L).

  6. ProBnp

    Time frame: once (within 24 hours of PCI)

    N-terminal pro-B-type natriuretic peptide (NT-proBNP) ) levels will be measured using routine blood samples collected during hospitalization. NT-proBNP is a biomarker used for diagnosing acute decompensated heart failure.

    • Unit of Measure: Picograms per milliliter (pg/mL).

  7. Time-Domain Indices of HRV

    Time frame: Before the intervention, immediately after the intervention (at 60 minutes), 24 hours post-intervention, and 48 hours post-intervention.

    Description: Time-domain indices of heart rate variability (HRV) measured using adedicated HRV monitor (emWave) on the patients' left index finger during 5 minutes at rest.

    • Metrics: SDNN (standard deviation of NN intervals) and RMSSD (root mean square of successive differences).
    • Units of Measure: Milliseconds (ms).
    • Description: Time-domain indices of heart rate variability (HRV) measured using a dedicated HRV monitor (emWave) on the patients' left index finger during 5 minutes at rest.
    • Metrics: SDNN (standard deviation of NN intervals) and RMSSD (root mean square of successive differences).
    • Units of Measure: Milliseconds (ms).
    • Description: Time-domain indices of heart rate variability (HRV) measured using a dedicated HRV monitor (emWave) on the patients' left index finger during 5 minutes at rest.
    • Metrics: SDNN (standard deviation of NN intervals) and RMSSD (root mean square of successive differences).
    • Units of Measure: Milliseconds (ms).

  8. Frequency-Domain Indices of HRV

    Time frame: : Before the intervention, immediately after the intervention (at 60 minutes), 24 hours post-intervention, and 48 hours post-intervention.

    Frequency-domain indices of heart rate variability (HRV) measured using a dedicated HRV monitor (emWave) on the patients' left index finger during 5 minutes at rest.• Metrics: LF (low frequency), HF (high frequency), and LF/HF ratio.• Units of Measure: Absolute power (ms²) or normalized units (nu).

Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Collaborators

  • University of Haifa
  • University of Oklahoma

Registry information

Official study title

Effects of Early Non-invasive Vagus Nerve Stimulation on Infarct Damage and Functioning After Acute ST-elevation Myocardial Infarction

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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