Transcranial Magnetic Stimulation for Sympathetic Hyperactivity and Inflammatory Response in Patients With Acute Myocardial Infarction: A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in heart rate variability (SDNN) from baseline to day 7
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
Active rTMS Group
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.
干预措施: 1-Hz repetitive transcranial magnetic stimulation (rTMS) (Device)
Sham rTMS Group
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.
干预措施: Sham repetitive transcranial magnetic stimulation (sham rTMS) (Device)
结局指标
主要结局
Change in heart rate variability (SDNN) from baseline to day 7
时间窗: Baseline and Day 7 (end of treatment)
次要结局
未报告次要终点
研究者
Xue Yu
Professor, Doctoral Supervisor, Department of Cardiology
Beijing Hospital