TMS for Sympathetic Hyperactivity and Inflammation in Acute Myocardial Infarction

NCT07842770 | Recruiting DMC

• 1 other identifier: BJ-2025-121
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether repetitive transcranial magnetic stimulation (rTMS) can improve sympathetic hyperactivity and inflammatory responses in patients with acute myocardial infarction (AMI), as well as evaluate its safety and tolerability. The main questions it aims to answer are: Can 1-Hz low-frequency rTMS targeting the right dorsolateral prefrontal cortex improve heart rate variability (SDNN) among patients with acute myocardial infarction? Is rTMS safe and well-tolerated for patients with acute myocardial infarction? Researchers will compare real rTMS versus sham rTMS to see if real rTMS can reduce sympathetic over-activation and inflammation in AMI patients. Participants will:

• Receive either real repetitive transcranial magnetic stimulation or sham stimulation for 7 consecutive days on top of standard-of-care medication for AMI
• Complete clinical assessments including electrocardiogram, Holter monitoring, echocardiography, blood laboratory tests for inflammatory markers at baseline, day 7, day 30, and 3-month follow-up
• Undergo resting-state functional magnetic resonance imaging (rs-fMRI) scans at baseline and day 7
• Fill out psychological and quality-of-life questionnaires (PHQ-9, SF-36) at scheduled study visits
• Attend follow-up clinic visits to record adverse events and major adverse cardiovascular events

Conditions

Acute Myocardial Infarction (AMI)

Outcome Measures

Primary Outcomes (1)

• Change in heart rate variability (SDNN) from baseline to day 7

  Baseline and Day 7 (end of treatment)

Study Arms (2)

Active rTMS Group

EXPERIMENTAL

Participants receive 1-Hz repetitive transcranial magnetic stimulation (rTMS) targeting the right dorsolateral prefrontal cortex, once daily for 7 consecutive days, in addition to standard medical therapy for acute myocardial infarction.

Device: 1-Hz repetitive transcranial magnetic stimulation (rTMS)

Sham rTMS Group

SHAM COMPARATOR

Participants receive sham rTMS with identical procedure, coil placement and noise, without real magnetic stimulation, once daily for 7 consecutive days, in addition to standard medical therapy for acute myocardial infarction.

Device: Sham repetitive transcranial magnetic stimulation (sham rTMS)

Interventions

1-Hz repetitive transcranial magnetic stimulation (rTMS) DEVICE

1 Hz low-frequency repetitive transcranial magnetic stimulation targeting the right dorsolateral prefrontal cortex, delivered once daily for 7 consecutive days. The stimulation is given on top of standard medication for acute myocardial infarction.

Active rTMS Group

Sham repetitive transcranial magnetic stimulation (sham rTMS) DEVICE

Sham repetitive transcranial magnetic stimulation with identical coil placement, operation noise and treatment schedule, without real magnetic field output. The intervention is delivered once daily for 7 consecutive days, combined with standard medical therapy for acute myocardial infarction.

Sham rTMS Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 30 to 75 years (inclusive), no restriction on sex;
• Diagnosed with acute myocardial infarction (AMI) in accordance with the Fourth Universal Definition of Myocardial Infarction (2018 ESC/ACC/AHA/WHF), with typical clinical manifestations, electrocardiographic changes and dynamic elevation of cardiac biomarkers;
• Received standardized reperfusion therapy (thrombolysis or percutaneous coronary intervention, PCI) with hemodynamic stability;
• Killip class I-II;
• Evidence of sympathetic activation: resting heart rate ≥90 beats per minute (after excluding confounders such as fever, thyroid dysfunction and severe anemia); reduced heart rate variability (e.g., SDNN \<100 ms) or frequency-domain indices indicating sympathetic predominance (e.g., elevated LF/HF ratio).

You may not qualify if:

• Severe cardiac dysfunction: Killip class ≥ III, or left ventricular ejection fraction (LVEF) \<30%;
• Contraindications to TMS: history of seizure, intracranial surgery or cranial trauma, intracranial/intra-cranial metallic implants, implanted pacemaker or implantable cardioverter-defibrillator;
• Active severe infection, ongoing anti-tumor treatment, or severe hepatic/renal insufficiency (judged comprehensively by clinical and laboratory findings);
• Pregnant or breastfeeding women, or those with definite pregnancy plan during the study period;
• Alcohol or substance dependence, psychiatric or cognitive disorders resulting in poor adherence;
• Participation in another interventional clinical trial within the past 3 months that may interfere with interpretation of study results;
• Prior TMS treatment for other diseases;
• Other conditions judged by investigators to make the participant unsuitable for enrollment (e.g., uncontrolled persistent myocardial ischemia, refractory arrhythmia, need for urgent cardiac surgery).

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital, National Center of Gerontology

Beijing, Beijing Municipality, 100730, China

RECRUITING

Central Study Contacts

Xue Yu, MD

CONTACT

86+13910417876; yuxuemd@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Doctoral Supervisor, Department of Cardiology

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: May 17, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)