丹参三七方治疗颈动脉斑块的真实世界回顾性队列研究

注册号:

Registration number:

ITMCTR2025000264

最近更新日期:

Date of Last Refreshed on:

2025-02-14

注册时间:

Date of Registration:

2025-02-14

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

丹参三七方治疗颈动脉斑块的真实世界回顾性队列研究

Public title:

A Real-World Retrospective Cohort Study of Salvia and Notoginseng Formula for the Treatment of Carotid Plaque

注册题目简写:

English Acronym:

研究课题的正式科学名称:

丹参三七方治疗颈动脉斑块的真实世界回顾性队列研究

Scientific title:

A Real-World Retrospective Cohort Study of Salvia and Notoginseng Formula for the Treatment of Carotid Plaque

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:

路孟凯

研究负责人:

李运伦

Applicant:

Lu mengkai

Study leader:

Li yunlun

申请注册联系人电话:

Applicant telephone:

13203813250

研究负责人电话:

Study leader's telephone:

13869102760

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:

mengkailu0912@163.com

研究负责人电子邮件:

Study leader's E-mail:

li.yunlun@163.com

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:

山东省济南市长清区大学科技园大学路4655号

研究负责人通讯地址:

山东省济南市文化西路42号

Applicant address:

No. 4655 University Road University Science Park Changqing District Jinan City Shandong Province

Study leader's address:

No. 42 Wenhua West Road Jinan City Shandong Province

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:

山东中医药大学

Applicant's institution:

Shandong University of Traditional 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:

(2025)伦审第(013)号-KY

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:

山东中医药大学附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2025/1/26 0:00:00

伦理委员会联系人:

袁杰

Contact Name of the ethic committee:

Yuan Jie

伦理委员会联系地址:

山东省济南市经十路16369号

Contact Address of the ethic committee:

No. 16369 Jingshi Road Jinan City Shandong Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

0531-68616733

伦理委员会联系人邮箱:

Contact email of the ethic committee:

dzyethics@163.com

研究实施负责(组长)单位:

山东中医药大学附属医院

Primary sponsor:

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

山东省济南市文化西路42号

Primary sponsor's address:

No. 42 Wenhua West Road Jinan City Shandong Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东

市(区县):

济南

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东中医药大学附属医院

具体地址:

山东省济南市文化西路42号

Institution
hospital:

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Address:

No. 42 Wenhua West Road Jinan City Shandong Province

经费或物资来源:

自拟课题,经费自筹

Source(s) of funding:

Self-proposed topics and self-funded

研究疾病:

颈动脉斑块

研究疾病代码:

Target disease:

Carotid plaque

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

队列研究

Cohort study

研究所处阶段:

Study phase:

回顾性研究

Retrospective study

研究目的:

通过收集真实世界数据,以丹参三七方为暴露因素建立回顾性队列,评价丹参三七方对于患者的患者颈动脉内膜-中层厚度的变化、颈动脉斑块的数量、性质、大小、心血管危险事件、不适症状等方面的改善情况,验证其临床疗效。

Objectives of Study:

By collecting real-world data and establishing a retrospective cohort with Salvia and Notoginseng Formula as the exposure factor the study aims to evaluate the effects of this formula on changes in carotid intima-media thickness (CIMT) the number nature and size of carotid plaques cardiovascular risk events and the improvement of discomfort symptoms in patients thereby verifying its clinical efficacy.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)参考《超声评价颈动脉易损斑块中国专家共识 (2023版)》和《中国头颈部动脉粥样硬化诊治共识(2017版)》标准:颈动脉动脉粥样硬化包括颈动脉IMT增加、颈动脉斑块和狭窄,甚至闭塞,IMT增加定义为IMT≥1.0 mm,颈动脉斑块定义为局灶IMT≥1.5mm,或侵犯到腔≥0.5 mm或与周围IMT值相比超过50%,颈动脉狭窄定义为狭窄程度≥50%,甚至闭塞。IMT增加和颈动脉斑块也被定义为早期颈动脉粥样硬化。 (2)年龄大于18岁,性别不限。 (3)电子病历数据完整。

Inclusion criteria

(1) Referencing the criteria from the "Chinese Expert Consensus on the Ultrasound Evaluation of Vulnerable Carotid Plaque (2023 Edition)" and the "Chinese Consensus on the Diagnosis and Treatment of Cervical and Cerebral Atherosclerosis (2017 Edition)": Carotid atherosclerosis includes increased carotid intima-media thickness (IMT) carotid plaque stenosis and even occlusion. Increased IMT is defined as IMT ≥ 1.0 mm. Carotid plaque is defined as focal IMT ≥ 1.5 mm or encroachment into the lumen ≥ 0.5 mm or an increase of more than 50% compared to the surrounding IMT values. Carotid stenosis is defined as a degree of stenosis ≥ 50% and even occlusion. Increased IMT and carotid plaque are also defined as early-stage carotid atherosclerosis. (2) Age greater than 18 years with no gender restrictions. (3) Complete electronic medical record data

排除标准:

(1)心脑血管病急性期患者,有介入或手术适应证的高危患者。 (2)除外其他继发性血脂异常患者(如肾病综合征、胆汁淤积性黄疸等)。 (3)妊娠和哺乳期妇女。 (4)有精神疾患、不能很好合作者。 (5)经检查确认有严重心脏疾病、重度神经官能症患者及心、肝、肾功能不全者。 (6)有重度内分泌、造血系统、肝、肾等原发性疾病、恶性肿瘤、精神病患者。 (7)未纠正的甲亢、甲状腺功能减退症者;肾病综合症、糖尿病及急性肝胆疾病患者。 (8)6个月内曾患严重脑血管意外、心脏疾患、严重创伤、重大手术者及其他一般情况不稳定且预后不良的原发性疾病

Exclusion criteria:

(1) Patients in the acute phase of cardiovascular and cerebrovascular diseases and high-risk patients with indications for interventional or surgical treatment. (2) Patients with secondary dyslipidemia due to other causes (such as nephrotic syndrome cholestatic jaundice etc.). (3) Pregnant and breastfeeding women. (4) Patients with mental disorders who cannot cooperate well. (5) Patients with severe heart disease severe neurosis or significant dysfunction of the heart liver or kidneys confirmed by examination. (6) Patients with severe primary diseases of the endocrine system hematopoietic system liver or kidneys malignant tumors or mental illness. (7) Patients with uncorrected hyperthyroidism or hypothyroidism; patients with nephrotic syndrome diabetes or acute hepatobiliary diseases. (8) Patients who have suffered from severe cerebrovascular accidents heart diseases severe trauma or major surgeries within the past 6 months as well as those with other primary diseases that are unstable and have a poor prognosis.

研究实施时间:

Study execute time:

From 2025-02-20

To      2026-02-20

征募观察对象时间:

Recruiting time:

From 2025-02-21

To      2026-02-19

干预措施:

Interventions:

组别:

对照组

样本量:

461

Group:

Control group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

暴露组

样本量:

461

Group:

Exposure group

Sample size:

干预措施:

丹参三七方

干预措施代码:

Intervention:

Danshen Sanqi Decoction

Intervention code:

样本总量 Total sample size : 922

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

山东

市(区县):

济南

Country:

china

Province:

Shandong

City:

Jinan

单位(医院):

山东中医药大学附属医院

单位级别:

三级甲等医院

Institution/hospital:

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Level of the institution:

Grade A tertiary hospital

测量指标:

Outcomes:

指标中文名:

颈动脉斑块

指标类型:

主要指标

Outcome:

Carotid plaque

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:

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):

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

none

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

试验完成后由山东中医药大学附属医院伦理委员会审核原始数据,并发表学术论文

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

After the trial is completed the Ethics Committee of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine will review the original data and publish an academic paper

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:

以CRF表格和病历的形式收集患者信息,保证信息准确、及时与完整,并将CRF表和病历信息建立数据库、对数据进行标准化处理,保证数据的有效性、一致性。为了确保本研究中涉及的所有个人信息得到严格的保护,遵循相关法律法规并保障受试者隐私,所有收集的数据将在数据录入阶段进行匿名化或去标识化处理,删除或替换与个人身份相关的任何直接标识符(如姓名、身份证号码等),确保研究人员无法通过数据追溯到个体身份。研究数据将存储在符合安全标准的数据库中,所有电子数据将在加密保护下保存。仅限于参与研究的核心成员才能访问研究数据,且每位研究人员的访问权限将根据其工作需要进行严格限定。

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

Patient information will be collected in the form of CRF forms and medical records to ensure that the information is accurate timely and complete. The CRF forms and medical record information will be used to establish a database standardize the data and ensure the validity and consistency of the data. In order to ensure that all personal information involved in this study is strictly protected comply with relevant laws and regulations and protect the privacy of the subjects all collected data will be anonymized or de-identified during the data entry stage and any direct identifiers related to personal identity (such as name ID number etc.) will be deleted or replaced to ensure that researchers cannot trace individual identities through data. Research data will be stored in a database that meets security standards and all electronic data will be stored under encrypted protection. Only core members involved in the study can access the research data and the access rights of each researcher will be strictly limited according to their work needs.

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):

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