PDF(Pubmed)
Abstract：
UNASSIGNED: Slow flow/no-reflow (SF-NR) during percutaneous coronary intervention (PCI) is associated with poor prognosis of patients with acute myocardial infarction (AMI). Currently, effective treatment is not available for SF-NR. Electroacupuncture (EA) has shown significant efficacy as an adjuvant therapy for many cardiovascular diseases by improving microcirculation and reducing ischemia-reperfusion injury. However, its effects on SF-NR in the AMI patients during PCI are not clear. This pilot trial aims to determine the efficacy of intraoperative EA in alleviating SF-NR in AMI patients undergoing PCI.
UNASSIGNED: This prospective, single-center, randomized controlled, pilot trial will recruit 60 AMI patients scheduled for PCI at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, China. The patients will be randomized in a 1:1 ratio into the EA or the control groups. Patients in the control group will undergo standard PCI. Patients in the EA group will undergo intraoperative electroacupuncture while undergoing standard PCI. Incidence of SF-NR is the primary outcome for this study. This study will also assess secondary outcomes including cardiac biomarkers, inflammatory biomarkers, pain and anxiety scores, electrocardiography parameters, traditional Chinese medicine (TCM) symptom score, and major adverse cardiovascular and cerebrovascular events (MACCE). All the included patients will undergo laboratory tests including routine blood tests, levels of electrolytes, as well as liver and renal function tests. Patients will be followed up for 1 month after the procedure.
UNASSIGNED: This pilot trial will provide evidence for the potential benefits of intraoperative EA in improving microvascular perfusion and preventing or alleviating SF-NR during PCI in patients with AMI. If proven effective, intraoperative EA will provide a new and effective strategy against SF-NR and provide evidence for subsequent multicenter trials.
UNASSIGNED: ClinicalTrials.gov, identifier (ChiCTR2300072265). Registered on 8 June 2023.
UNASSIGNED: This prospective, single-center, randomized controlled, pilot trial will recruit 60 AMI patients scheduled for PCI at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, China. The patients will be randomized in a 1:1 ratio into the EA or the control groups. Patients in the control group will undergo standard PCI. Patients in the EA group will undergo intraoperative electroacupuncture while undergoing standard PCI. Incidence of SF-NR is the primary outcome for this study. This study will also assess secondary outcomes including cardiac biomarkers, inflammatory biomarkers, pain and anxiety scores, electrocardiography parameters, traditional Chinese medicine (TCM) symptom score, and major adverse cardiovascular and cerebrovascular events (MACCE). All the included patients will undergo laboratory tests including routine blood tests, levels of electrolytes, as well as liver and renal function tests. Patients will be followed up for 1 month after the procedure.
UNASSIGNED: This pilot trial will provide evidence for the potential benefits of intraoperative EA in improving microvascular perfusion and preventing or alleviating SF-NR during PCI in patients with AMI. If proven effective, intraoperative EA will provide a new and effective strategy against SF-NR and provide evidence for subsequent multicenter trials.
UNASSIGNED: ClinicalTrials.gov, identifier (ChiCTR2300072265). Registered on 8 June 2023.
摘要：
■经皮冠状动脉介入治疗（PCI）期间的慢血流/无复流（SF-NR）与急性心肌梗死（AMI）患者的不良预后相关。目前,SF-NR没有有效的治疗方法。电针通过改善微循环和减轻缺血再灌注损伤,作为多种心血管疾病的辅助治疗手段,已显示出显著的疗效。然而,其对AMI患者PCI期间SF-NR的影响尚不清楚。这项初步试验旨在确定术中EA在缓解接受PCI的AMI患者的SF-NR中的功效。
■这个前景，单中心,随机对照,试点试验将招募60名计划在岳阳中西医结合医院接受PCI的AMI患者，中国。患者将以1:1的比例随机分为EA或对照组。对照组患者将接受标准PCI。EA组的患者将在接受标准PCI的同时接受术中电针。SF-NR的发生率是本研究的主要结果。这项研究还将评估次要结果，包括心脏生物标志物，炎症生物标志物，疼痛和焦虑评分，心电图参数,中医症状积分,和主要不良心脑血管事件（MACCE）。所有纳入的患者将接受实验室检查，包括常规血液检查，电解质的水平，以及肝肾功能检查.手术后将对患者进行1个月的随访。
■这项初步试验将为AMI患者术中EA在改善微血管灌注和预防或减轻PCI期间SF-NR的潜在益处提供证据。如果证明有效,术中EA将为SF-NR提供新的有效策略,并为后续多中心试验提供证据.
■ClinicalTrials.gov,标识符(ChiCTR2300072265)。2023年6月8日注册。
■这个前景，单中心,随机对照,试点试验将招募60名计划在岳阳中西医结合医院接受PCI的AMI患者，中国。患者将以1:1的比例随机分为EA或对照组。对照组患者将接受标准PCI。EA组的患者将在接受标准PCI的同时接受术中电针。SF-NR的发生率是本研究的主要结果。这项研究还将评估次要结果，包括心脏生物标志物，炎症生物标志物，疼痛和焦虑评分，心电图参数,中医症状积分,和主要不良心脑血管事件（MACCE）。所有纳入的患者将接受实验室检查，包括常规血液检查，电解质的水平，以及肝肾功能检查.手术后将对患者进行1个月的随访。
■这项初步试验将为AMI患者术中EA在改善微血管灌注和预防或减轻PCI期间SF-NR的潜在益处提供证据。如果证明有效,术中EA将为SF-NR提供新的有效策略,并为后续多中心试验提供证据.
■ClinicalTrials.gov,标识符(ChiCTR2300072265)。2023年6月8日注册。
