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The effect of transcutaneous auricular vagus nerve stimulation on fractional flow reserve and autonomic nervous system regulation in patients with acute myocardial infarction: A randomized controlled clinical trial

The effect of transcutaneous auricular vagus nerve stimulation on fractional flow reserve and autonomic nervous system regulation in patients with acute anterior myocardial infarction: A randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112576
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial infarction

Interventions

TaVNS group:Upon arrival in the catheterization laboratory, right auricular vagus nerve stimulation therapy was initiated immediately. The stimulation parameters were as follows: frequency 20Hz, pulse
Control group:Conventional coronary intervention, sham stimulation treatment (power on, indicator light display, wearing ear electrode, no current). All patients received standardized coronary heart d

Sponsors

Shanghai Jiao Tong University School of Medicine Affiliated Songjiang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed clinically with STEMI occurring within 24 hours and planning to undergo PCI surgery; (2) Age range: 18-80 years old; (3) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Congenital heart disease, history of myocardial infarction, severe valvular heart disease, known renal failure (GFR<30ml/min), atrial fibrillation, pacemaker patients; (2) Known active malignant tumor diseases; (3) Unable to cooperate with treatment for serious mental illness; (4) There are situations where ear skin damage or infection affects the implementation of taVNS; (5) Pregnant women or women who are planning to conceive in the next 6 months; (6) Patients with a life expectancy of less than 6 months; (7) The researchers believe that patients who are not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Quantitative flow ratio;

Secondary

MeasureTime frame
Levels of inflammatory markers (IL-6, IL-1ß, TNF-a, CRP) were measured 24 hours after surgery.;Cardiac troponin T(cTnT), creatine kinase isoenzyme (CK-MB), and cardiac troponin T(CTNT) were measured at admission and 24 hours after operation. N-terminal pro-B-type natriuretic peptide (NT-proBNP);The values of heart rate and blood pressure before and after each treatment were recorded, and the mean value, standard deviation (SD), coefficient of variation (CV(%)=SD/ mean *100%), fluctuation range d= maximum value -minimum value, and blood pressure variability and heart rate variability were analyzed;Myocardium was assessed by CMR at 7 days and 6 months after surgery Salvage score (MSI), six-minute walk distance (6WMD), quality of life (SF-36);

Countries

China

Contacts

Public ContactLei Hou; Haiyan Shi

Shanghai Jiao Tong University School of Medicine Affiliated Songjiang Hospital

Dr_houlei@163.com+86 21 6772 0001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026