结合眼底微血管变化和中医证型的缺血性中风的复发风险预测模型

注册号:

Registration number:

AMCTR-OPC-18000229 

注册号获得时间:

Date of releasing the registration number:

2018/11/20 10:31:57 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

结合眼底微血管变化和中医证型的缺血性中风的复发风险预测模型 

Public title:

Prediction of recurrent stroke with retinal vascular information and key elements of traditional Chinese medicine syndrome 

研究课题的正式科学名称:

结合眼底微血管变化和中医证型的缺血性中风的复发风险预测模型 

Scientific title:

Prediction of recurrent stroke with retinal vascular information and key elements of traditional Chinese medicine syndrome 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

黄杏贤 

研究负责人:

卓缘圆 

Applicant:

Huang xingxian 

Study leader:

Zhuo Yuanyuan 

申请注册联系人电话:

Applicant telephone:

13632822278 

研究负责人电话:

Study leader's telephone:

13530969797 

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:

732545909@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

qinyuan64@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:

中国广东省深圳市福田区福华路1号 

研究负责人通讯地址:

中国广东省深圳市福田区福华路1号 

Applicant address:

No.1 Fuhua Rd, Futian District, Shenzhen,Guangdong,China 

Study leader's address:

No.1 Fuhua Rd, Futian District, Shenzhen,Guangdong,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:

深圳市中医院 

Applicant's institution:

Shenzhen Traditional Chinese Medicine hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

深中医伦审(研)[2018]75 

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:

广州中医药大学深圳附属医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of shenzhen Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-10-29 

研究实施负责(组长)单位:

深圳市中医院 

Primary sponsor:

Shenzhen Traditional Chinese Medicine hospital 

研究实施负责(组长)单位地址:

深圳市中医院 

Primary sponsor's address:

Shenzhen Traditional Chinese Medicine hospital 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

深圳市

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市中医院

具体地址:

中国广东省深圳市福田区福华路1号

Institution
hospital:

Shenzhen Traditional Chinese Medicine hospital

Address:

No.1 Fuhua Rd, Futian District, Shenzhen,Guangdong,China

经费或物资来源:

国家自然科学基金委员会 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

复发中风 

Target disease:

recurrent stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational 

研究所处阶段:

I期临床试验 

Study phase:

Phase I 

研究目的:

通过对研究对象的一般资料、合并病史、临床检验检查报告、眼底微血管影像、前期脑卒中随访调查资料、中医证型的归纳和整理,并随访发生缺血性中风后治疗情况、死亡、复发事件。建立基于眼底微血管变化、中医证型和临床风险因素的缺血性中风复发的广义线性生存预测模型。 

Objectives of Study:

By observing the changes of fundus microvessel after ischemic stroke, combining with TCM syndromes and the clinical risk factors related to stroke recurrence, and taking the recurrence within 2 years as the outcome index, the above indexes were screened, and a generalized linear survival prediction model for early recurrence of ischemic stroke was established to establish secondary prevention of stroke. The program provides clues to improve the accuracy of prediction of ischemic stroke recurrence. 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

①符合西医脑梗死诊断及中医缺血性中风诊断。②年龄30-80 岁。③发病时间≤半年。④美国国立卫生研究院卒中量表NIHSS 评分≥4-24 分。 

Inclusion criteria

①It accords with the diagnosis of cerebral infarction in western medicine and the diagnosis of ischemic stroke in TCM. ②The age is 30-80 years old. ③The onset time is less than half a year. ④the NIHSS score of the National Institutes of Health Stroke Scale is more than 4-24 points. 

排除标准:

①短暂性脑缺血发作(TIA)。②剔除椎--基底动脉系脑梗死、脑出血或蛛网膜下腔出血。③经检查证实由脑肿瘤、脑外伤、血液病等引起的卒中患者。④合并有肝、肾、造血系统、内分泌系统等严重疾病及骨关节病。⑤精神障碍或严重痴呆。⑥存在意识障碍者。 

Exclusion criteria:

①Transient ischemic attack (TIA). ② Elimination of vertebral basilar artery infarction, cerebral hemorrhage or subarachnoid hemorrhage. ③the stroke patients caused by brain tumor, brain trauma and hematopathy were confirmed by examination. ④combined liver, kidney, hematopoietic system, endocrine system and other serious diseases and osteoarthropathy. ⑤Mental disorders or severe dementia.⑥Patients with mental disorders. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

样本量:

342

Group:

No

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

深圳市 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市中医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shenzhen Traditional Chinese Medicine hospital  

Level of the institution:

three A hospital 

测量指标:

Outcomes:

指标中文名:

眼底微血管特征

指标类型:

主要指标 

Outcome:

retinal vascular characteristic

Type:

Primary indicator 

指标中文名:

中风中医证型

指标类型:

主要指标 

Outcome:

TCM syndromes of stroke

Type:

Primary indicator 

指标中文名:

临床风险要素

指标类型:

主要指标 

Outcome:

Clinical risk factors

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

No

Tissue:

No

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 30 years
最大 Max age 80 years

随机方法(请说明由何人用什么方法产生随机序列):

性别:

男女均可

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

no

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

Resman临床试验公共管理平台(http://www.medresman.org)

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

Resman Clinical Trial Management Public Platform

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

1. 研究数据:病例报告表,眼底检查数据 2. 数据库:Excel,眼底微血管测试数据

The repository and management of the data(Please specify what repository will be used for management of the metadata):

1.Research Data: Case Report Form,the data of retinal vessels. 2.Databsse: Excel, the data of retinal vessels。

创建人:

Creater Name:

 2018-11-01
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