TMS for Sympathetic Hyperactivity and Inflammation in Acute Myocardial Infarction
Transcranial Magnetic Stimulation for Sympathetic Hyperactivity and Inflammatory Response in Patients With Acute Myocardial Infarction: A Clinical Study
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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Xue Yu, MD
- Telefonnummer: 86+13910417876
- E-mail: yuxuemd@aliyun.com
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100730
- Rekruttering
- Beijing Hospital, National Center of Gerontology
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Kontakt:
- Yi Ye, MD (Doctor of Medicine)
- Telefonnummer: 86+15181627926
- E-mail: yye_bjyy@163.com
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-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
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. |
|
Sham-komparator: 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. |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in heart rate variability (SDNN) from baseline to day 7
Tidsramme: Baseline and Day 7 (end of treatment)
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Baseline and Day 7 (end of treatment)
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- BJ-2025-121
Plan for individuelle deltagerdata (IPD)
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