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- Klinische proef NCT07842770
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
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Xue Yu, MD
- Telefoonnummer: 86+13910417876
- E-mail: yuxuemd@aliyun.com
Studie Locaties
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100730
- Werving
- Beijing Hospital, National Center of Gerontology
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Contact:
- Yi Ye, MD (Doctor of Medicine)
- Telefoonnummer: 86+15181627926
- E-mail: yye_bjyy@163.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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-vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Change in heart rate variability (SDNN) from baseline to day 7
Tijdsspanne: Baseline and Day 7 (end of treatment)
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Baseline and Day 7 (end of treatment)
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- BJ-2025-121
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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