- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Xue Yu, MD
- Telefonnummer: 86+13910417876
- E-Mail: yuxuemd@aliyun.com
Studienorte
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100730
- Rekrutierung
- 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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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Schein-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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change in heart rate variability (SDNN) from baseline to day 7
Zeitfenster: Baseline and Day 7 (end of treatment)
|
Baseline and Day 7 (end of treatment)
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- BJ-2025-121
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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