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针刺对急性冠脉综合征患者冠脉介入术后主要不良心血管事件发生率影响的临床研究

注册号：

Registration number：

ITMCTR2025001349

最近更新日期：

Date of Last Refreshed on：

2025-07-09

注册时间：

Date of Registration：

2025-07-09

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

针刺对急性冠脉综合征患者冠脉介入术后主要不良心血管事件发生率影响的临床研究

Public title：

Clinical Study on the Effect of Acupuncture on Major Adverse Cardiovascular Events in Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention

注册题目简写：

针刺对ACS患者MACE影响的临床研究

English Acronym：

Impact of Acupuncture on MACE in ACS Patients: A Clinical Study

研究课题的正式科学名称：

针刺对急性冠脉综合征患者冠脉介入术后主要不良心血管事件发生率影响的临床研究

Scientific title：

Clinical Study on the Effect of Acupuncture on Major Adverse Cardiovascular Events in Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention

研究课题的正式科学名称简写：

针刺对ACS患者MACE影响的临床研究

Scientific title acronym：

Impact of Acupuncture on MACE in ACS Patients: A Clinical Study

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

范俊

研究负责人：

冯玲

Applicant：

Jun Fan

Study leader：

Ling Feng

申请注册联系人电话：

Applicant telephone：

17317592298

研究负责人电话：

Study leader's telephone：

18917237229

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

fanjun010600@163.com

研究负责人电子邮件：

Study leader's E-mail：

532717104@shutcm.edu.cn

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

上海市虹口区甘河路110号

研究负责人通讯地址：

上海市虹口区甘河路110号

Applicant address：

No. 110Gan he roadShanghai

Study leader's address：

No. 110Gan he roadShanghai

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

上海中医药大学附属岳阳中西医结合医院

Applicant's institution：

Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2025-050

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025/3/26 0:00:00

伦理委员会联系人：

殷从全

Contact Name of the ethic committee：

Congquan Yin

伦理委员会联系地址：

上海市虹口区甘河路110号

Contact Address of the ethic committee：

No. 110Gan he roadShanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-65151782-8122

伦理委员会联系人邮箱：

Contact email of the ethic committee：

yyyyllwyh@163.com

研究实施负责（组长）单位：

上海中医药大学附属岳阳中西医结合医院

Primary sponsor：

Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital

研究实施负责（组长）单位地址：

上海市虹口区甘河路110号

Primary sponsor's address：

No. 110Gan he roadShanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

虹口区

Country：

China

Province：

Shanghai

City：

Hong Kou

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

具体地址：

上海市虹口区甘河路110号

Institution
hospital：

Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital

Address：

No. 110Gan he roadShanghai

经费或物资来源：

自筹

Source(s) of funding：

self-raised

研究疾病：

急性冠脉综合征

研究疾病代码：

Target disease：

Acute Coronary Syndrome

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

本课题观察针刺在心脏康复中减少PCI术后院内、围术期的主要不良心血管事件发生率，改善短期不良预后的效果及安全性。本课题拟通过观察并分析针刺对急性冠脉综合征患者PCI术后1月内不良心血管事件发生率、心肌酶谱变化（血清高敏肌钙蛋白cTnl、CK-MB、超敏C反应蛋白、N末端B型利钠肽前体（NT-pro BNP））、NRS胸痛评分量表、心脏彩超检查、改良Barthel指数、六分钟步行测试的影响，探究针刺对ACS患者PCI术后预后的影响，为院内Ⅰ期康复探索一种安全有效的心脏康复潜在新途径，为针刺在康复领域的融入与结合提供临床经验和方法，旨在更好地发挥中医药治疗优势，使更多患者从中受益。

Objectives of Study：

This study aims to investigate the efficacy and safety of acupuncture in cardiac rehabilitation for reducing in-hospital and perioperative major adverse cardiovascular events (MACE) following percutaneous coronary intervention (PCI) while improving short-term clinical outcomes.Through systematic observation and analysis this research will evaluate the effects of acupuncture on: 1) The incidence of MACE within 1 month post-PCI in patients with acute coronary syndrome (ACS). 2) Changes in cardiac biomarkers.3) Clinical parameters.The study seeks to explore acupuncture's impact on post-PCI prognosis in ACS patients with the goal of establishing a safe and effective novel approach for Phase I in-hospital cardiac rehabilitation. By providing clinical evidence and methodology for integrating acupuncture into rehabilitation practice this research aims to optimize the therapeutic advantages of Traditional Chinese Medicine ultimately benefiting a broader patient population.

药物成份或治疗方案详述：

对照组：西药常规治疗+呼吸运动训练 西药常规治疗：患者在CCU中，均按照急性冠脉综合征西药常规治疗方案干预。参照2017年欧洲心脏病协会《急性ST段抬高心肌梗死患者管理指南》，2016年中华医学会心血管病协会《急性非ST段抬高急性冠脉综合征诊断和治疗指南》。介入术后无禁忌者，予阿司匹林100mg每日1次，替格瑞洛90mg每日2次或氯吡格雷75mg每日1次，阿托伐他汀20mg每晚1次，β-受体阻滞剂、血管紧张素转换酶抑制剂、血管紧张素II受体拮抗剂，视患者基础情况逐渐滴定剂量。 呼吸运动训练：根据《中西医结合Ⅰ期心脏康复共识》予PCI术后患者循序渐进的呼吸运动训练，包括腹式缩唇呼吸、中医呼吸导引。中医呼吸导引以岳康养心健肺功为主，该训练适用于运动能力受限、心肺功能下降等无法耐受常规站位功法和有氧运动的患者，该训练由上海中医药大学附属岳阳中西医结合医院康复科心肺康复团队研发，将功法中“放松功”与“六字诀”进行合理筛选整合，总结出一套呼吸养心健肺功，已广泛运用于心肌梗死早期、慢性阻塞性肺疾病加重期、心肺外科手术早期、脑卒中肺功能障碍等。腹式缩唇呼吸每次５～１０min，２次／ｄ。中医呼吸导引，1次／ｄ。中医呼吸导引功法（岳康养心健肺功）：1. 闭目冥心：掌心向上，左手在上，右手在下，拇指尖相对，两目轻闭，平心静气，保持自然呼吸30s。2. 放松头颈：睁眼，保持均匀的自然呼吸，尽量自然放松颈部及脊柱，向正前方自然低头，再向右、向后、向左、再回到向前，绕圈2次，每次30s，之后反向绕圈2次。先缓慢伸直脊柱，再缓慢抬起颈部，颌微内收，平视前方。3. 脊背松展：吸气掌心向上提至胸前，呼气向外推掌，低头含胸，牵拉脊柱，腹式呼吸，吸气加大脊柱拉伸力度，呼吸放松丹田，共做4次，两手垂落体侧放松，自下而上依次缓慢直起脊柱、颈部，平视前方。4. 浑圆开合：腹式呼吸，两掌相对，松肩沉肘，胸前抱球，吸气开掌，两臂向外棚力，呼吸合掌相距一拳，一开一合为一次，共做4次，向下按掌收于胯前。5. 叉掌按顶：两手相搓，令手心发热，两掌收于腹前，十指交叉，翻掌向上，吸气上托，伸膝，踝趾屈，绷平脚面，翻掌向下按顶，踝背伸，脚尖向上，一托一按为一遍，共做4遍。每日固定由1名已取得执业医师证的医师进行一对一训练，以消除因训练人员不同而导致的混杂因素。 干预组：西药常规治疗+呼吸运动训练+针刺治疗 针刺治疗：参照《经络腧穴学》中穴位定位及操作手法，患者取仰卧位，选用华佗牌一次性无菌针灸针规格0.25 mm × 40 mm，常规消毒后，每日固定由1名已取得执业医师证的医师进行操作，以消除因施针人员不同而导致的混杂因素。选穴:双侧内关、郄门、每天1次，连续5天，每次约20min，在具体操作中，嘱患者仰卧位，不要随意变动体位，放松肢体，配合医生进行操作。在施针部位消毒后，快速进针，得气后施予补泻手法，以局部明显酸胀感为宜。取双侧内关，位于前臂掌侧，当曲泽与大陵的连线上，腕横纹上2寸，掌长肌腱与桡侧腕屈肌腱之间，直刺0.5～1寸，得气后予泻法。取双侧郄门，位于在前臂掌侧，当曲泽与大陵的连线上，腕横纹上5寸，直刺0.5～1寸，得气后予泻法。泻法：施以捻转泻法，大拇指向后用力捻转，然后轻力向前退回，每次捻转幅度360°，每分钟60次，持续捻转1 min。 西药常规治疗+呼吸运动训练：同对照组。

Description for medicine or protocol of treatment in detail：

Control group: The treatment plan incorporates both conventional Western medicine and respiratory exercise training. Conventional Western medicine treatment: All patients in the CCU were treated according to the conventional Western medicine treatment protocol for acute coronary syndrome. The 2017 European Society of Cardiology Guidelines for the Management of Patients with Acute ST-Elevation Myocardial Infarction and the 2016 Chinese Medical Association Cardiovascular Disease Association Guidelines for the Diagnosis and Treatment of Acute Non-ST-Elevation Acute Coronary Syndrome were used as references. For patients lacking contraindications subsequent to intervention aspirin 100 mg was administered once daily ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily. Atorvastatin 20 mg was administered once daily at bedtime and beta-blockers angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were prescribed with doses titrated gradually based on the patient's baseline condition. Respiratory exercise training: According to the "Consensus on Integrated Traditional and Western Medicine for Phase I Cardiac Rehabilitation" patients who have undergone PCI should be administered progressive respiratory exercise training including abdominal pursed-lip breathing and traditional Chinese medicine breathing exercises. Traditional Chinese medicine (TCM) breathing exercises principally consist of the Yue Kang Heart and Lung Health Exercise which is appropriate for patients with restricted exercise capacity and diminished cardiopulmonary function who are unable to tolerate conventional standing exercises and aerobic exercise. The training was developed by the Cardiopulmonary Rehabilitation Team of the Rehabilitation Department of the Yueyang Hospital of Integrated Traditional and Western Medicine which is affiliated with Shanghai University of Traditional Chinese Medicine. The program's selection and integration of the "relaxation exercises" and "six-character formula" from the exercises is reasonable. A set of breathing exercises for nourishing the heart and strengthening the lungs is summarized. These exercises have been widely applied in the early stages of myocardial infarction exacerbation of chronic obstructive pulmonary disease early stages of cardiopulmonary surgery and pulmonary dysfunction after stroke. The abdominal pursed-lip breathing technique should be performed for a duration of 5–10 minutes per session with each session occurring twice daily.According to the principles of Traditional Chinese Medicine (TCM) the administration of breathing guidance is recommended on a daily basis. The following breathing guidance exercises are derived from the principles of Traditional Chinese Medicine (TCM): the Yueyang Heart-Nourishing and Lung-Strengthening Exercises. 1. In order to facilitate the process of relaxation the subject is instructed to close their eyes and calm their mind. The subject is to position their palms in an upward orientation with the left hand positioned above and the right hand below and to ensure that the thumbs are in contact with one another. They are then to maintain a state of calm and peacefulness while keeping their eyes slightly closed and breathing naturally for a duration of 30 seconds. 2. It is imperative to relax the head and neck. It is imperative to maintain even natural breathing and to relax the neck and spine as much as possible. The subject is then instructed to lower their head in a gentle forward motion followed by a lateral rotation to the right backward left and then forward. This sequence of movements is repeated twice with each repetition lasting for a duration of 30 seconds. Subsequently the circular motion is repeated in the counterclockwise direction twice. The spine should be straightened gradually and then the neck should be lifted with the chin being slightly tucked in while maintaining a forward gaze. 3. Spinal relaxation: Inhale with the palms facing upward toward the chest. Exhale while pushing the palms outward. Then lower the head and round the chest. Stretch the spine breathing diaphragmatically. While inhaling increase the intensity of the spinal stretch. Relax the lower abdomen while breathing. Repeat this sequence four times. Allow the hands to hang loosely at the sides. Slowly straighten the spine and neck from the bottom to the top. Look straight ahead. 4. The act of opening and closing the circular aperture is described as follows: In order to execute the following sequence of movements the subject should first breathe deeply then place their palms together relax their shoulders and lower their elbows. They should then hold a ball in front of their chest inhale and open their palms. They should extend their arms outward breathe and close their palms to a distance of one fist apart. It is important to note that one opening and closing of the palms constitutes one repetition. This sequence should be repeated four times. Finally the subject should press their palms downward and bring them to their hips.5. Crossed Palms Pressing the Crown: The following sequence of actions should be executed sequentially: first rub the palms together vigorously until they are warm; second position both palms at the anterior aspect of the abdomen; third interlock the fingers and rotate the palms upward; fourth inhale deeply and lift the palms upward; fifth extend the knees flex the ankles and flex the toes; sixth flatten the feet; seventh rotate the palms downward and press the crown; eighth extend the ankles backward; and ninth point the toes upward. One repetition of the lift and press is designated as one cycle. The total number of cycles is set at four. Daily training is conducted in a one-on-one manner by a licensed physician with the objective of eliminating variability caused by different trainers. The intervention group is comprised of: The treatment plan incorporates a combination of conventional Western medicine breathing exercises and acupuncture.Acupuncture treatment: For a comprehensive overview of acupoint localization and manipulation techniques refer to the seminal text "Meridian and Acupointology." The patient is positioned supine. The utilization of Huatuo brand disposable sterile acupuncture needles with a specification of 0.25 millimeters by 40 millimeters is recommended. Following a standard disinfection protocol a licensed physician performs the procedure daily to mitigate confounding factors associated with variations in practitioner expertise. The selection of acupoints is a critical component of this process. The Neiguan and Ximen points were stimulated bilaterally with each point being stimulated for approximately 20 minutes per session. This stimulation was administered once daily for a period of five consecutive days. During the procedure the patient is instructed to assume a supine position refrain from changing position maintain relaxed limbs and cooperate with the physician. Following the meticulous cleansing of the needling site the needle is expeditiously inserted. Following the attainment of the qi sensation tonification or dispersion techniques are implemented with the objective of eliciting a perceptible sensation of soreness and distension at the local site. It is imperative to select both sides of Neiguan which is located on the palmar side of the forearm. The point is found along the line connecting Quze and Daling two cun above the wrist crease. This is located between the palmaris longus tendon and the radial wrist flexor tendon. The needle should be inserted perpendicularly at a depth of 0.5–1 centimeters and a dispersing technique should be applied subsequent to the acquisition of the qi sensation. The Ximen acupoint located on the palmar side of the forearm at the intersection of the Quze and Daling lines approximately five cun above the wrist crease should be selected bilaterally. The needle should be inserted perpendicularly at a depth of 0.5–1 centimeters and a dispersing technique should be employed subsequent to the acquisition of the Qi sensation. Dispersing Method: The twisting dispersing technique is to be applied with the thumb exerting force in a backward twisting motion followed by a gentle retraction in the forward direction. Each rotation should encompass a 360° amplitude executed at a frequency of 60 times per minute with the sequence continuing for a duration of one minute. The conventional Western medical treatment is complemented by respiratory exercise training. This outcome aligns with that of the control group.

纳入标准：

1符合急性冠脉综合征诊断并患病后首次已行急诊PCI术后24小时的患者； 2年龄≥40周岁且≤80周岁，性别不限； 3同意参加本研究并签署知情同意书者。

Inclusion criteria

1. Patients diagnosed with acute coronary syndrome who have undergone emergency percutaneous coronary intervention (PCI) within 24 hours of symptom onset. 2. Individuals aged 40 years or older and 80 years or younger are eligible for inclusion in the study irrespective of gender. 3. Patients who have voluntarily consented to participate in this study and have signed the requisite informed consent form.

排除标准：

1 急诊就诊时病情危重生命体征严重不平稳者； 2 合并肝、肾、造血系统等严重损害者； 3 研究对象本人因酗酒、认知障碍等原因不能配合； 4 术前合并严重心脏并发症，如心源性休克、恶性心律失常、急性心力衰竭等； 5 针刺部位皮肤破损或感染等不适合针刺者； 6 不同意在我院住院治疗而难以完成后续观察者； 7 近期4周内作过手术及有出血倾向者； 8 最近1个月内参与过或正在参加其他心脏康复相关研究； 9 妊娠及哺乳期妇女； 10具有心脏超声的禁忌症人群。

Exclusion criteria：

1 Patients with critically ill conditions and severely unstable vital signs at the time of emergency department visit; 2 Patients with severe damage to the liver kidneys hematopoietic system or other organs; 3 Study participants who are unable to cooperate due to alcohol abuse cognitive impairment or other reasons; 4 Patients with severe cardiac complications prior to surgery such as cardiogenic shock malignant arrhythmias or acute heart failure; 5 Patients with skin damage or infection at the acupuncture site making acupuncture unsuitable; 6 Patients who refuse hospitalization at our hospital and cannot complete follow-up observations; 7 Patients who have undergone surgery within the past 4 weeks or have a tendency to bleed; 8 Patients who have participated in or are currently participating in other cardiac rehabilitation-related studies within the past month; 9 Pregnant or breastfeeding women; 10 Patients with contraindications for cardiac ultrasound.

研究实施时间：

Study execute time：

从From 2025-03-26

至To      2026-02-23

征募观察对象时间：

Recruiting time：

从From 2025-03-26

至To      2026-02-01

干预措施：

Interventions：

组别：

对照组

样本量：

38

Group：

Conventional treatment group

Sample size：

干预措施：

常规药物治疗联合呼吸运动训练

干预措施代码：

Intervention：

Conventional drug therapy combined with respiratory exercise training

Intervention code：

组别：

干预组

样本量：

38

Group：

intervention group

Sample size：

干预措施：

对双侧内关、郄门进行针刺、每天1次，连续5天，每次约20min。西药常规治疗+呼吸运动训练同对照组

干预措施代码：

Intervention：

The acupuncture treatment consisted of bilateral Neiguan and Ximen stimulation administered once daily for a period of five consecutive days with each session lasting approximately 20 minutes.Conventional Western medicine treatment and respiratory exercise training are the same as in the control group.

Intervention code：

样本总量 Total sample size ： 76

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海市

市(区县)：

虹口区

Country：

China

Province：

Shanghai

City：

hong kou

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

单位级别：

三级甲等医院

Institution/hospital：

Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital

Level of the institution：

Grade IIIA hospital

测量指标：

Outcomes：

指标中文名：

心肌酶谱变化

指标类型：

次要指标

Outcome：

"Changes in myocardial enzyme profiles

Type：

Secondary indicator

测量时间点：

术后第一天及术后第七天

测量方法：

抽血检测

Measure time point of outcome：

The first day after surgery and the seventh day after surgery

Measure method：

blood test

指标中文名：

改良Barthel指数评估

指标类型：

次要指标

Outcome：

modified Barthel index

Type：

Secondary indicator

测量时间点：

PCI术后第七天、术后1月

测量方法：

采用改良Barthel指数评定通过评估患者在日常活动中的表现

Measure time point of outcome：

PCI postoperative day 7, postoperative 1 month

Measure method：

The modified Barthel Index is used to assess patients' performance in daily activities.

指标中文名：

胸痛评分

指标类型：

次要指标

Outcome：

Chest pain rating scale

Type：

Secondary indicator

测量时间点：

术后第一天、术后第七天

测量方法：

采用VAS视觉评分量表

Measure time point of outcome：

The first day after surgery, the seventh day after surgery

Measure method：

Using the VAS visual analog scale

指标中文名：

心功能指数

指标类型：

次要指标

Outcome：

Cardiac function index

Type：

Secondary indicator

测量时间点：

术后第一天、术后第七天

测量方法：

岳阳医院心内科超声医师对检测结果进行测量，比较两组患者的左室射血分数(left ventricular ejection fraction,LVEF)、左心房前后直径(left atrial diameter,LAD)、左心室后壁收缩末期厚度(left ventricular posterior wall end-systolic thickness,LVPWS)、左心室后壁厚度(left ventricular posterior wall thickness,LVPWT) 及收缩末期室间隔厚度(end-systolic ventricular septal thickness,IVSS)。

Measure time point of outcome：

The first day after surgery, the seventh day after surgery

Measure method：

The echocardiography physicians in the Department of Cardiology at Yueyang Hospital measured the test results and compared the left ventricular ejection fraction (LVEF), left atrial diameter (LAD), left ventricular posterior wall end-systolic thickness (LVPWS), left ventricular posterior wall thickness (LVPWT), and end-systolic ventricular septal thickness (IVSS).

指标中文名：

术后1个月内MACE发生情况

指标类型：

主要指标

Outcome：

Occurrence of Major Adverse Cardiovascular Events within 1 month after surgery

Type：

Primary indicator

测量时间点：

术后1月时

测量方法：

MACE率=主要不良心血管事件人数/每组总人数×100%

Measure time point of outcome：

One month after surgery

Measure method：

MACE rate = Number of major adverse cardiovascular events / Total number of participants in each group × 100%

指标中文名：

六分钟步行测试

指标类型：

次要指标

Outcome：

6-minute walk test

Type：

Secondary indicator

测量时间点：

PCI术后第七天

测量方法：

要求患者直线距离>30米的走廊内尽可能快地行走，测定6min的步行距离并记录其心率、血压和主观疲劳度评分。

Measure time point of outcome：

Seventh day after PCI surgery

Measure method：

Ask patients to walk as fast as possible in a corridor with a straight-line distance of >30 meters, measure the walking distance in 6 minutes, and record their heart rate, blood pressure, and subjective fatigue score.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 40 岁
Min age years
最大 80 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

研究采用简单随机分组的方法予以分组，将全部入选患者按就诊顺序编号，采用 SPSS 27.0 统计软件产生随机数字及随机分配表，按分组随机编号将患者分入干预组和对照组进行治疗。一组为对照组，即 PCI术后CCU常规治疗；干预组即PCI术后CCU常规治疗并采取针刺干预治疗。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Randomization and Intervention Protocol The study employed a simple randomization method for participant allocation. All enrolled patients were sequentially numbered according to their admission order. Using SPSS Statistics 27.0 software random numbers were generated to create a randomization schedule. Based on this predetermined allocation sequence patients were assigned to either the intervention group or control group. Study Groups: Control Group: Received standard CCU (Cardiac Care Unit) post-PCI conventional therapy alone Intervention Group: Received both standard CCU post-PCI care and acupuncture treatment

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

是

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

原始数据公开将在试验研究完成后6月后联系原始作者获得

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The disclosure of raw data will be obtained by contacting the original author six months after the completion of the experimental research

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

将采用病例记录表(Case Record Form, CRF)进行病例记录

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case records will be documented using case record forms (CRFs).

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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