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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Xue Yu, MD
- 전화번호: 86+13910417876
- 이메일: yuxuemd@aliyun.com
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100730
- 모병
- Beijing Hospital, National Center of Gerontology
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연락하다:
- Yi Ye, MD (Doctor of Medicine)
- 전화번호: 86+15181627926
- 이메일: yye_bjyy@163.com
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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. |
|
가짜 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in heart rate variability (SDNN) from baseline to day 7
기간: Baseline and Day 7 (end of treatment)
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Baseline and Day 7 (end of treatment)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- BJ-2025-121
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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