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ST Elevation Myocardial Infarction (STEMI)NCT06865716

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

A study testing Active noninvasive vagus nerve stimulation and Chum electrode attached to patient's lower ear lobe in people with ST Elevation Myocardial Infarction (STEMI), run by Bnai Zion Medical Center at 1 site in Israel.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 75 years
What is being tested?
Active noninvasive vagus nerve stimulation and Chum electrode attached to patient's lower ear lobe
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteIsrael
Study dates
1 Oct 2023to 30 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 9Show fewer
  • Anaesthetize patient.
  • Mechanical ventilated patient.
  • Participation in another trial

Trial locations and contacts

1 site in 1 country.

Israel1 site

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

    Haifa, Haifa District, 3104802

Other trials in Israel

About this study

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

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?
Read more

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).

Being tested
Active noninvasive vagus nerve stimulation, Chum electrode attached to patient's lower ear lobe
Keywords
RCT, Non invasive vagal nerve stimulation, STEMI, Cardiac Functioning
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active noninvasive vagus nerve stimulationDevice

    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 lobeOther

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

Study groups in NCT06865716
Study groupRoleWhat they receive
Post PCI STEMI patients treated with early active noninvasive vagus nerve stimulationExperimentalThe patients received 60 minutes of electrical vagus nerve stimulation via electrode attached to the ear.
Receives: Device: Active noninvasive vagus nerve stimulation
Post PCI STEMI patients received the clip stimulator on the lower ear lobe without stimulationSham comparatorPost PCI STEMI patients in the control arm received the clip stimulator on the lower ear lobe without stimulation
Receives: Other: Chum electrode attached to patient's lower ear lobe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wall Motion Score Index

    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

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

  2. Left ventricular ejection fraction (LVEF)

    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.

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

Secondary outcomes (8)

  1. survival

    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.

    Measured: one month after the intervention and one year after

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

    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..

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

  3. inflammatory markers of CRP

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

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

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

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

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

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

  5. Troponin

    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).

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

  6. ProBnp

    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).

    Measured: once (within 24 hours of PCI)

  7. Time-Domain Indices of HRV

    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).

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

  8. Frequency-Domain Indices of HRV

    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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start1 Oct 2023
  3. Primary completion5 Jan 2025
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06865716
Sponsor's protocol ID
169-21-BNZ
Status last verified
Mar 2025
First submitted
19 Jan 2025
Last updated
10 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Active noninvasive vagus nerve stimulation and Chum electrode attached to patient's lower ear lobe in people with ST Elevation Myocardial Infarction (STEMI), run by Bnai Zion Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wall Motion Score Index (time frame: One to 2 days after stimulation: 24-48 hours post-stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06865716.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.

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