Characteristics of biomarker on dermal sensitization for myocardial ischemia-reperfusion injury

注册号:

Registration number:

ITMCTR2024000180

最近更新日期:

Date of Last Refreshed on:

2024-08-07

注册时间:

Date of Registration:

2024-08-07

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

心脏支架术后心肌再灌注损伤患者敏化表征的生物特性研究

Public title:

Characteristics of biomarker on dermal sensitization for myocardial ischemia-reperfusion injury

注册题目简写:

English Acronym:

研究课题的正式科学名称:

心脏支架术后心肌再灌注损伤患者敏化表征的生物特性研究

Scientific title:

Characteristics of biomarker on dermal sensitization for myocardial ischemia-reperfusion injury

研究课题的正式科学名称简写:

Scientific title acronym:

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:

李岩

研究负责人:

乔海法

Applicant:

Yan Li

Study leader:

Haifa Qiao

申请注册联系人电话:

Applicant telephone:

17635921201

研究负责人电话:

Study leader's telephone:

18220046518

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:

17635921201@163.com

研究负责人电子邮件:

Study leader's E-mail:

1511006@sntcm.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:

陕西省咸阳市秦都区陕西中医药大学针灸推拿学院

研究负责人通讯地址:

陕西省咸阳市秦都区陕西中医药大学针灸推拿学院

Applicant address:

College of Acupuncture and Tuina, Shaanxi University of Chinese Medicine, Xianyang 712046, Shaanxi, China

Study leader's address:

College of Acupuncture and Tuina, Shaanxi University of Chinese Medicine, Xianyang 712046, Shaanxi, China

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:

陕西中医药大学针灸推拿学院

Applicant's institution:

College of Acupuncture and Tuina, Shaanxi University of Chinese Medicine

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:

SZFYIEC-PJ-2024年第[135]号

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

陕西中医药大学附属医院伦理委员会

Name of the ethic committee:

the Ethics Committee of the Affiliated Hospital of Shaanxi University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/19 0:00:00

伦理委员会联系人:

钟慧慧

Contact Name of the ethic committee:

Huihui Zhong

伦理委员会联系地址:

陕西中医药大学附属医院

Contact Address of the ethic committee:

the Affiliated Hospital of Shaanxi University of Chinese Medicine

伦理委员会联系人电话:

Contact phone of the ethic committee:

029-33377941

伦理委员会联系人邮箱:

Contact email of the ethic committee:

szfyllwyh@163.com

研究实施负责(组长)单位:

陕西中医药大学附属医院

Primary sponsor:

the Affiliated Hospital of Shaanxi University of Chinese Medicine

研究实施负责(组长)单位地址:

陕西省咸阳市秦都区陕西中医药大学附属医院

Primary sponsor's address:

the Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang 712000, Shaanxi, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

陕西省

市(区县):

咸阳市

Country:

China

Province:

Shaanxi

City:

Xianyang

单位(医院):

陕西中医药大学附属医院

具体地址:

陕西省咸阳市秦都区陕西中医药大学附属医院

Institution
hospital:

the Affiliated Hospital of Shaanxi University of Chinese Medicine

Address:

the Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang 712000, Shaanxi, China

经费或物资来源:

国家重点研发计划[2022YFC3500701]

Source(s) of funding:

National Key Research and Development Program of China [2022YFC3500701]

研究疾病:

心脏支架术后心肌缺血再灌注损伤

研究疾病代码:

Target disease:

myocardial ischemia reperfusion injury

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

横断面

Cross-sectional

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

通过对心脏支架术后心肌再灌注损伤患者敏化区、非敏化区生物活性物质的表达及分布差异进行研究,探索内脏疾病引起穴位敏化的物质基础和分子生物学机制,以期构建穴位敏化的分子生物学标准,指导心脏支架手术围术期的临床选穴。

Objectives of Study:

By studying the difference in expression and distribution of bioactive substances in sensitized and non-sensitized areas of patients with cardiac reperfusion injury after cardiac stenting, the material basis and molecular biological mechanism of acupoint sensitization caused by visceral diseases were explored, with a view to establishing molecular biological standards for acupoint sensitization and guiding clinical point selection during perioperative period of cardiac stent surgery.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

MIRI组: (1)满足《欧洲心脏病学会指南》2023版关于非ST段抬高型急性冠脉综合征的诊断标准; (2)一周内行PCI手术并植入至少一枚支架; (3)性别不限,年龄≥18周岁,<85周岁; (4)自愿参加该研究并签署知情同意书。 注:同时符合以上4项,方可纳入本研究。 对照组: (1)一周内体检报告无异常; (2)性别不限,年龄≥18周岁,<85周岁; (3)自愿参加该研究并签署知情同意书。 注:同时符合以上3项,方可纳入本研究。

Inclusion criteria

MIRI patients: (1) meeting the diagnostic criteria of non-ST elevation acute coronary syndrome in 2023 ESC Guidelines for the management of acute coronary syndromes. (2) received percutaneous coronary intervention within a week. (3) aged 18 to 85 years. (4) willing to participate in this study, and sign on informed consent. Healthy subjects: (1) received a health examination within a week, and confirmed to be in good health. (2) aged 18 to 85 years, and matching the MIRI patients. (3) willing to participate in this study, and sign on informed consent.

排除标准:

(1)STEMI患者,心电图表现为持续ST段抬高(至少两个连续的起始于J点的ST段抬高:①V2~V3导联≥2.5mm,男性<40岁,或≥2mm,男性≥40岁,或≥1.5mm,女性不限年龄;②其他导联≥1mm,除左室肥大或左束支传导阻滞外;③右胸导联V3R~V4R,或后背导联V7~V9≥0.5mm); (2)合并心力衰竭、心律失常、心肌疾病、心脏瓣膜病、感染性心内膜炎等其他心血管疾病; (3)患有恶性肿瘤、严重感染疾病、炎症性疾病、自身免疫性疾病、血液系统疾病、严重脑血管疾病; (4)采样区皮肤有肿物、皮炎、湿疹、荨麻疹、毛囊炎、大疱性皮肤病、肉芽肿性皮肤病、代谢性皮肤病等皮肤病; (5)具有发热症状; (6)患有精神类疾病或伴有严重心理障碍,不能配合者; (7)妊娠期、哺乳期妇女; (8)既往3个月内,使用未经批准的药物参加了任何其他药物研究或者治疗研究。 注:凡符合上述任何1条的患者,均予以排除。

Exclusion criteria:

(1) diagnosed as ST-elevation myocardial infarction, with persistent ST-segment elevation or ST-segment elevation equivalents on electrocardiogram. (2) combined with disorders of rhythm, disorders of the heart, muscles, valves, and pericardium, and peripheral vascular disease. (3) suffering from neoplastic disorders, hematopoietic disorders, disorders of hemostasis, infectious diseases, immune-mediated, inflammatory, and rheumatologic disorders. (4) combined with fever. (5) suffering from psychiatric disorders, and unable to cooperate. (6) participating in any other study using an unapproved drug within 3 months.

研究实施时间:

Study execute time:

From 2024-08-10

To      2025-06-20

征募观察对象时间:

Recruiting time:

From 2024-08-31

To      2025-06-20

干预措施:

Interventions:

组别:

健康组

样本量:

24

Group:

healthy group

Sample size:

干预措施:

形敏,痛敏,热敏,电敏

干预措施代码:

Intervention:

morphological sensitization; algetic sensitization; pyretic sensitization; conductive sensitization

Intervention code:

组别:

MIRI组

样本量:

24

Group:

MIRI group

Sample size:

干预措施:

形敏,痛敏,热敏,电敏

干预措施代码:

Intervention:

morphological sensitization; algetic sensitization; pyretic sensitization; conducive sensitization

Intervention code:

样本总量 Total sample size : 48

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

陕西省

市(区县):

Country:

China

Province:

Shaanxi

City:

单位(医院):

陕西中医药大学附属医院

单位级别:

三级甲等

Institution/hospital:

the Affiliated Hospital of Shaanxi University of Chinese Medicine

Level of the institution:

top three hospitals

测量指标:

Outcomes:

指标中文名:

mRNA

指标类型:

主要指标

Outcome:

mRNA

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

间质液

组织:

Sample Name:

interstitial fluid

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:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 85
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):

研究员乔使用Excel生成随机数字(每个随机数匹配一类敏化类型),24名MIRI患者或健康受试者按入组顺序分配随机数字及敏化类型,并采用信封法进行盲法。

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

24 MIRI patients or healthy subjects will be given a sensitization type/sampling point, in order of entry. Sensitization types/sampling points will be generated in Excel. The opaque envelope will be used for blinding, with the order of entry on cover of the envelope, and sensitization type/sampling points inside. The work will be performed by Investigator Qiao, and will be blinded for other Investigators.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

原始数据预计于2025年6月30日前以文献形式公开

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

The original data will be available in literature by June 30, 2025.

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:

数据采集将采用病例记录表(Case Record Form, CRF)。

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

Case Record Form will be used for data collection.

数据管理委员会:

Data Managemen Committee:

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above