ChiCTR2600119976 版本V1.1 版本创建时间2026/03/07 14:08:13 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600119976 

最近更新日期：

Date of Last Refreshed on：

2026-03-06 14:33:27 

注册时间：

Date of Registration：

2026-03-06 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

颈动脉粥样硬化斑块中低回声区占比与同侧前循环缺血性卒中的关系及斑块低回声区影像与病理对比研究

Public title：

The relationship between the proportion of hypoechoic areas in carotid atherosclerotic plaques and ipsilateral anterior circulation ischemic stroke, and the comparative study of the imaging of hypoechoic areas in plaques and the pathological conditions

注册题目简写：

English Acronym：

研究课题的正式科学名称：

颈动脉粥样硬化斑块中低回声区占比与同侧前循环缺血性卒中的关系及斑块低回声区影像与病理对比研究

Scientific title：

The relationship between the proportion of hypoechoic areas in carotid atherosclerotic plaques and ipsilateral anterior circulation ischemic stroke, and the comparative study of the imaging of hypoechoic areas in plaques and the pathological conditions

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：

易雪婷 

研究负责人：

惠品晶 

Applicant：

Xueting Yi 

Study leader：

Pinjing Hui 

申请注册联系人电话：

Applicant telephone：

+86 138 6206 1643

研究负责人电话：

Study leader's telephone：

+86 139 1313 2822

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：

yixueting508@outlook.com

研究负责人电子邮件：

Study leader's E-mail：

pinjing-hui@163.com

申请单位网址(自愿提供)：

Applicant 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：

江苏省苏州市姑苏区平海路899号

研究负责人通讯地址：

江苏省苏州市姑苏区平海路899号

Applicant address：

No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

Study leader's address：

No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu 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：

苏州大学附属第一医院颈脑血管超声科

Applicant's institution：

The Department of Cerebrovascular Ultrasound, Affiliated First Hospital of Soochow University

研究负责人所在单位：

苏州大学附属第一医院颈脑血管超声科

Affiliation of the Leader：

The Department of Cerebrovascular Ultrasound, Affiliated First Hospital of Soochow University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2025)伦审批第1275号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

苏州大学附属第一医院伦理委员会

Name of the ethic committee：

The Ethics Committee of the First Affiliated Hospital of Soochow University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-24 00:00:00

伦理委员会联系人：

陈罡

Contact Name of the ethic committee：

Gang Chen

伦理委员会联系地址：

江苏省苏州市姑苏区平海路899号

Contact Address of the ethic committee：

No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 512 6797 2861

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

苏州大学附属第一医院

Primary sponsor：

The Ethics Committee of the First Affiliated Hospital of Soochow University

研究实施负责（组长）单位地址：

江苏省苏州市姑苏区平海路899号

Primary sponsor's address：

No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu 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)：

江苏

市(区县)：

苏州

Country：

China

Province：

Jangsu

City：

Suzhou

单位(医院)：

苏州大学附属第一医院

具体地址：

江苏省苏州市姑苏区平海路899号

Institution
hospital：

The Ethics Committee of the First Affiliated Hospital of Soochow University

Address：

No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

经费或物资来源：

苏州大学技术开发合作项目（H211064）、2024 苏州大学附属第一医院博习临床研究重点项目（BXLC2024006）、姑苏卫生人才计划（GSWS2023090）、江苏省自然科学基金（BK20250371）

Source(s) of funding：

Suzhou University Technology Development Cooperation Project (H211064), 2024 Suzhou University Affiliated First Hospital Boxi Clinical Research Key Project (BXLC2024006), Gusu Health Talent Program (GSWS2023090), Jiangsu Province Natural Science Foundation (BK20250371)

Target disease：

Atherosclerotic plaque of the internal carotid artery

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

探讨颈总-颈内动脉粥样硬化斑块中低回声区占比与同侧大脑半球出现缺血性脑卒中的关系及斑块低回声区影像与病理对比研究。  

Objectives of Study：

To explore the relationship between the proportion of hypoechoic areas in the common carotid - internal carotid artery atherosclerotic plaques and the occurrence of ischemic stroke in the ipsilateral cerebral hemisphere, as well as the comparison study between the imaging of the hypoechoic areas in the plaques and the pathological findings.

药物成份或治疗方案详述：

1. 在苏州大学附属第一医院影像系统中收集 2024.01.01—2024.12.31 在苏州大学附属第一医院 48 小时内颈血管超声、TCD、颈脑血管 CTA 及 CTP 检查资料齐全的患者，并根据纳入排除标准选择研究对象。 2. 对符合纳排标准的患者颈动脉斑块低回声区占比进行分析，将斑块分为3 型（斑块回声低于邻近胸锁乳突肌回声，定义为低回声） 低回声斑块为主：低回声区域在最大纵切面积中占比超过 60%； 混合回声斑块：低回声区域在最大纵切面积中占比约为30%-60%； 低回声少量型斑块：低回声区域在最大纵切面积中占比小于 30%。 3. 从中随机选取 15 例颈动脉内膜切除术后标本，从既往保存标本保存罐（福尔马林液）中取出，对离体标本行 24 MHz 高频超声、Micro-CT 及组织病理学检查，实现影像特征与病理结构的精准对照。 

Description for medicine or protocol of treatment in detail：

1. In the imaging system of the First Affiliated Hospital of Soochow University, the data of patients who underwent 48-hour cervical vascular ultrasound, TCD, cervical-cerebral CTA and CTP examinations at the First Affiliated Hospital of Soochow University from January 1, 2024 to December 31, 2024 and had complete records were collected. Based on the inclusion and exclusion criteria, the research subjects were selected. 2. The proportion of low-echo areas in the carotid plaques of the patients meeting the inclusion and exclusion criteria was analyzed. The plaques were classified into 3 types (the echo of the plaque was lower than that of the adjacent sternocleidomastoid muscle, defined as low echo): Predominantly low-echo plaques: The low-echo area accounted for more than 60% of the maximum longitudinal section area; Mixed echo plaques: The low-echo area accounted for approximately 30% - 60% of the maximum longitudinal section area; Low-echo small amount type plaques: The low-echo area accounted for less than 30% of the maximum longitudinal section area. 3. 15 specimens of carotid endarterectomy after surgery were randomly selected from the preservation jars (formalin solution) of the previously stored specimens, and the isolated specimens were taken for 24 MHz high-frequency ultrasound, Micro-CT and histopathological examination to achieve precise comparison of imaging features and pathological structures. 

纳入标准：

2024.01.01—2024.12.31 在苏州大学附属第一医院 48 小时内颈血管超声、TCD、颈脑血管 CTA 及 CTP 检查资料齐全的患者。 (1)颈血管超声检测：单侧颈内动脉起始处上下延伸约 1cm 狭窄≥ 50%。 (2)颈血管超声检查 48 小时内有 TCD、颈脑血管 CTA 及 CTP 检查。 (3)CTP 提示为缺血性脑卒中患者。

Inclusion criteria

January 1, 2024 - December 31, 2024: Patients who underwent 48-hour comprehensive examinations including cervical vascular ultrasound, TCD, cervical-cerebral vascular CTA, and CTP at the First Affiliated Hospital of Soochow University. Inclusion criteria: Cervical vascular ultrasound: (1) Narrowing of the upper and lower parts of the unilateral internal carotid artery extending approximately 1 cm, with a stenosis of >= 50%. (2) Within 48 hours of the cervical vascular ultrasound examination, there were TCD, cervical-cerebral vascular CTA, and CTP examinations. (3) CTP indicated ischemic stroke patients.

排除标准：

(1) 有轻度（< 50%）狭窄或有闭塞。 (2) 有既往动脉内膜切除术或支架植入术或 STA-MCA bypass 术史。 (3) 有其他可能导致狭窄的原因，如夹层、血栓形成、烟雾病和纤维肌性发育不良。 (4) 超声学或影像学、临床学数据不完整。 (5) 颅内血管大脑中动脉和/或大脑前动脉中重度狭窄。 (6)排除其他病因导致缺血性脑卒中的患者。 (7)既往有缺血性脑卒中病史者。

Exclusion criteria：

(1) Mild (less than 50%) narrowing or occlusion. (2) History of endarterectomy or stent implantation or STA-MCA bypass surgery. (3) Other causes that may lead to narrowing, such as dissection, thrombosis, moyamoya disease, and fibromuscular dysplasia. (4) Incomplete ultrasound or imaging, clinical data. (5) Severe stenosis of the middle cerebral artery and/or anterior cerebral artery in the intracranial vessels. (6) Exclude patients with ischemic stroke caused by other etiologies. (7) Patients with a previous history of ischemic stroke.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2027-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-04 00:00:00 至 To 2027-01-31 00:00:00  

干预措施：

Interventions：

组别：

观察组

样本量：

75

Group：

Observation group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

 苏州 

Country：

China 

Province：

Jiangsu  

City：

Suzhou 

单位(医院)：

苏州大学附属第一医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Soochow University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

影像特征

指标类型：

主要指标

Outcome：

image features

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

病理结构

指标类型：

次要指标

Outcome：

Pathological structure

Type：

Secondary 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：

颈动脉粥样硬化斑块

组织：

Sample Name：

Carotid atherosclerotic plaque

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：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 85 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

在论文发表前，将数据留存在院内的数据库储存，数据清洗、脱敏且文章发表后，通过合适的公共数据库（如CNGBdb、Dryad、Figshare等）共享

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

Prior to publication, research data should be securely stored in the institution's internal database and undergo rigorous data cleaning and anonymization; following publication, the data should be made publicly available through recognized repositories such as CNGBdb, Dryad, and Figshare.

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：

在苏州大学附属第一医院影像系统中收集符合纳排标准的研究对象，并且记录患者年龄、性别、颈动脉粥样硬化斑块所在位置、颈动脉粥样硬化斑块分类、TCD 结果、CTP 结果。 从研究对象中随机选取 15 例颈动脉内膜切除术后标本，从既往标本保存罐（福尔马林液）中取出，对离体标本行 24 MHz 高频超声检查、Micro-CT 检查、HE 染色、Movat 染色、Von Kossa染色、普鲁士蓝染色、CD68 免疫组化染色、CD86 免疫组化染色、CD31 免疫组化染色及 CD31免疫荧光染色、CD68\CD86 免疫荧光双染，实现影像特征与病理结构的精准对照。

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

In the imaging system of the First Affiliated Hospital of Soochow University, the research subjects meeting the inclusion and exclusion criteria were collected, and the patient's age, gender, location of carotid atherosclerotic plaques, classification of carotid atherosclerotic plaques, TCD results, and CTP results were recorded. Randomly select 15 specimens from the carotid endarterectomy patients, and take them from the previous specimen storage tank (formalin solution). Perform 24 MHz high-frequency ultrasound examination, Micro-CT examination, HE staining, Movat staining, Von Kossa staining, Prussian blue staining, CD68 immunohistochemical staining, CD86 immunohistochemical staining, CD31 immunohistochemical staining and CD31 immunofluorescence staining, CD68/CD86 immunofluorescence double staining on the isolated specimens to achieve precise comparison of imaging features and pathological structures.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-03-06 14:33:10