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

NCT ID: NCT06865716

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-12-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Post PCI STEMI patients treated with early active noninvasive vagus nerve stimulation

The patients received 60 minutes of electrical vagus nerve stimulation via electrode attached to the ear.

Group Type: EXPERIMENTAL

Active noninvasive vagus nerve stimulation

Intervention Type: 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 .

Post PCI STEMI patients received the clip stimulator on the lower ear lobe without stimulation

Post PCI STEMI patients in the control arm received the clip stimulator on the lower ear lobe without stimulation

Group Type: SHAM_COMPARATOR

Chum electrode attached to patient's lower ear lobe

Intervention Type: OTHER

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

Interventions

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 .

Intervention Type: DEVICE

Chum electrode attached to patient's lower ear lobe

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Haifa

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: collaborator

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Idit.Dobretzky-Mery

Head of the cardiology and cardiac care unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Haifa, Haifa District, Israel

Countries

Israel

Other Identifiers

169-21-BNZ

Identifier Type: -

Identifier Source: org_study_id