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心血管-肾脏-代谢综合征认知评估前瞻性队列研究
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注册号：

Registration number：

 ChiCTR2600126339 

最近更新日期：

Date of Last Refreshed on：

 2026-06-08 10:12:21 

注册时间：

Date of Registration：

 2026-06-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

心血管-肾脏-代谢综合征认知评估前瞻性队列研究

Public title：

Prospective Cohort Study on Cognitive Assessment of Cardiovascular-Kidney-Metabolic Syndrome

注册题目简写：

English Acronym：

研究课题的正式科学名称：

心血管-肾脏-代谢综合征认知评估前瞻性队列研究

Scientific title：

Prospective Cohort Study on Cognitive Assessment of Cardiovascular-Kidney-Metabolic Syndrome

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：

徐靖 

研究负责人：

徐靖 

Applicant：

Xu Jing 

Study leader：

Xu Jing 

申请注册联系人电话：

Applicant telephone：

 +86 13912080023

研究负责人电话：

Study leader's
telephone：

+86 517 84952318

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：

 xj680390@126.com

研究负责人电子邮件：

Study leader's E-mail：

 xj680390@126.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：

中国江苏省淮安市淮阴区黄河西路1号

研究负责人通讯地址：

中国江苏省淮安市淮阴区黄河西路1号

Applicant address：

1 Hanghe West Road, Huaiyin District, Huai'an, Jiangsu, China

Study leader's address：

1 Hanghe West Road, Huaiyin District, Huai'an, Jiangsu, 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：

南京医科大学附属淮安第一医院

Applicant's institution：

The Affiliated Huai’an No.1 People's Hospital of Nanjing Medical University

研究负责人所在单位：

淮安市第一人民医院

Affiliation of the Leader：

Huai'an First People's 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：

 KY-2026-125-01

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：

淮安市第一人民医院医学伦理委员会

Name of the ethic committee：

Huai 'an First People's Hospital Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-05-06 00:00:00

伦理委员会联系人：

李浩

Contact Name of the ethic committee：

Li Hao

伦理委员会联系地址：

中国江苏省淮安市淮阴区黄河西路1号

Contact Address of the ethic committee：

1 Hanghe West Road, Huaiyin District, Huai'an, Jiangsu, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 517 84936880

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hasyyll@163.com

研究实施负责（组长）单位：

淮安市第一人民医院

Primary sponsor：

Huai'an First People's Hospital

研究实施负责（组长）单位地址：

中国江苏省淮安市淮阴区黄河西路1号

Primary sponsor's address：

1 Hanghe West Road, Huaiyin District, Huai'an, Jiangsu, 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)：

江苏

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

淮安市第一人民医院

具体地址：

中国江苏省淮安市淮阴区黄河西路1号

Institution
hospital：

Huai'an First People's Hospital

Address：

1 Hanghe West Road, Huaiyin District, Huai'an, Jiangsu, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

心血管-肾脏-代谢综合征（CKM综合征）、睡眠障碍、认知功能下降、轻度认知障碍（MCI）、痴呆  

Target disease：

Cardiovascular-kidney-metabolic syndrome, sleep disorder, cognitive decline, mild cognitive impairment, dementia

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

本研究旨在建立前瞻性队列，系统评估心血管-肾脏-代谢（CKM）综合征及其分期与认知与脑结构功能改变之间的关系，为高风险人群的早期识别、风险预警及预后评估提供依据。  

Objectives of Study：

The aim of this study is to establish a prospective cohort to systematically evaluate the associations between cardiovascular-kidney-metabolic (CKM) syndrome and its stages with changes in cognition and brain structure/function, thereby providing a basis for the early identification, risk warning, and prognostic assessment of high-risk populations.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1.既往明确诊断为痴呆，或存在明显认知障碍而无法完成认知评估者； 2.既往患有严重神经系统疾病，可能明显影响认知功能评估者，如脑卒中后遗症、帕金森 病、脑肿瘤、癫痫、脑外伤后遗症等； 3.伴有严重精神心理疾病或不能配合完成问卷及认知测试者； 4.存在严重视力、听力或语言交流障碍，导致无法完成认知评估者； 5.伴有严重系统性疾病或终末期疾病，预计难以完成长期随访者，如晚期恶性肿瘤、严重心力衰竭、严重呼吸功能不全等； 6.基线资料严重缺失，无法进行主要变量评估者。 MRI子队列在主队列基础上招募，排除标准包括： (1) 无法完成 MRI、PSG 或认知评估； (2) 影像或睡眠监测数据存在严重伪影或质量不合格； (3) 以中枢性睡眠呼吸暂停为主者

Exclusion criteria：

1.who have been clearly diagnosed with dementia, or who have obvious cognitive impairments and are unable to complete the cognitive assessment; 2.who have previously suffered from severe neurological disorders, which may significantly affect the assessment of cognitive functions, such as post-stroke sequelae, Parkinson's disease, brain tumors, epilepsy, and post-traumatic brain sequelae, etc. 3.Those with severe mental or psychological disorders or those who cannot cooperate in completing questionnaires and cognitive tests; 4.Those with severe visual, hearing or language communication impairments that prevent them from completing the cognitive assessment. 5.Those with severe systemic diseases or end-stage illnesses, who are expected to have difficulty completing long-term follow-up, such as advanced malignant tumors, severe heart failure, severe respiratory insufficiency, etc. 6.Missing key baseline data required for the primary analyses. The MRI subcohort is recruited from the main cohort. The exclusion criteria include: (1) inability to complete MRI, PSG, or cognitive assessments; (2) severe artifacts or inadequate quality in imaging or sleep monitoring data; (3) predominant central sleep apnea.

研究实施时间：

Study execute time：

从 From 2026-06-10 00:00:00至 To 2033-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-10 00:00:00 至 To 2028-05-10 00:00:00

干预措施：

Interventions：

组别：

MRI子队列(包含在主队列中）

样本量：

 1200

Group：

MRI Subcohort (included within the main cohort)

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

总体观察队列

样本量：

 6000

Group：

Overall observational cohort

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

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)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 淮安市第一人民医院 

单位级别：

 三级甲等 

Institution
hospital：

Huai'an First People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

随访期间新发轻度认知障碍（MCI）

指标类型：

主要指标

Outcome：

New-onset mild cognitive impairment (MCI) during follow-up

Type：

Primary indicator

测量时间点：

基线及随访期间每年评估一次，随访5年，并在条件允许时延长随访

测量方法：

新发轻度认知障碍（MCI）的诊断参考Petersen标准及NIA-AA核心临床标准。

Measure time point of outcome：

Assessed at baseline and annually during a 5-year follow-up, with follow-up extended to 10 years if

Measure method：

Incident mild cognitive impairment (MCI) will be diagnosed with reference to the Petersen criteria and the NIA-AA core clinical criteria.

指标中文名：

认知功能纵向变化

指标类型：

主要指标

Outcome：

Longitudinal change in cognitive function

Type：

Primary indicator

测量时间点：

基线及随访期间每年评估一次，随访5年，并在条件允许时延长随访至10年

测量方法：

采用 MoCA、MMSE 及综合认知 Z 评分在随访期间相对于基线的变化值及其年均变化斜率进行量化。

Measure time point of outcome：

Assessed at baseline and annually during a 5-year follow-up, with follow-up extended to 10 years if

Measure method：

Longitudinal change in cognitive function will be quantified by changes from baseline in MoCA, MMSE, and composite cognitive z scores, as well as their annualized rates of decline.

指标中文名：

新发心脑血管及代谢性事件

指标类型：

次要指标

Outcome：

Incident cardiovascular, cerebrovascular, and metabolic events

Type：

Secondary indicator

测量时间点：

基线及随访期间每年评估一次，随访5年

测量方法：

通过门诊或住院病历、体检资料、实验室检查结果、影像学资料及随访记录收集新发心血管事件、脑血管事件、代谢性事件及死亡信息，并依据预设临床诊断标准进行判定。死亡结局通过医院病历、随访记录或相关登记资料确认。

Measure time point of outcome：

The baseline will be evaluated once a year, and this will be done for a total of five years

Measure method：

New cardiovascular events, cerebrovascular events, metabolic events and death information were collected through outpatient or inpatient medical records, physical examination data, laboratory test results, imaging data and follow-up records, and were determined according to the preset clinical diagnostic criteria. The death outcome was confirmed through hospital medical records, follow-up records or relevant registration materials.

指标中文名：

各认知域功能变化

指标类型：

次要指标

Outcome：

Change in domain-specific cognitive function

Type：

Secondary indicator

测量时间点：

基线及随访期间每年评估一次，随访5年

测量方法：

采用标准化神经心理测验评估各认知域功能，包括记忆、执行功能、注意力、语言及信息处理速度等，并以各认知域测验评分在随访期间相对于基线的变化值和年变化斜率表示。

Measure time point of outcome：

The baseline will be evaluated once a year, and this will be done for a total of five years

Measure method：

Domain-specific cognitive function will be assessed using standardized neuropsychological tests covering memory, executive function, attention, language, and processing speed. Longitudinal change will be quantified by changes in domain-specific test scores from baseline and annual rates of change during follow-up.

指标中文名：

新发认知功能下降及新发痴呆

指标类型：

次要指标

Outcome：

New-onset decline in cognitive function and new-onset dementia

Type：

Secondary indicator

测量时间点：

基线及随访期间每年评估一次，随访5年

测量方法：

随访期间每年采用标准化神经心理测验（如MoCA、MMSE）评估多认知域轨迹，并使用FAQ评估日常功能。认知下降可通过可靠变化指数或纵向模型斜率判断。新发痴呆诊断则需由多学科裁定委员会依据DSM-5标准，综合认知评估、功能状态和临床病史，确认首次出现由认知下降导致独立生活能力受损的事件。功能评估是区分轻度认知损害与痴呆的关键。辅助可采集生物样本及影像用于探索性分析。

Measure time point of outcome：

The baseline will be evaluated once a year, and this will be done for a total of five years

Measure method：

During the follow-up period, standardized neuropsychological tests (such as MoCA, MMSE) were used annually to assess the trajectories of multiple cognitive domains, and the FAQ was used to evaluate daily functions. Cognitive decline could be determined by the reliable change index or the slope of the longitudinal model. The diagnosis of new-onset dementia required a multidisciplinary adjudication committee to confirm the first occurrence of an event where impaired independent living ability was

指标中文名：

日常功能状态下降

指标类型：

次要指标

Outcome：

Decline in daily functional status

Type：

Secondary indicator

测量时间点：

基线及随访期间每年评估一次，随访5年

测量方法：

随访期间每年采用FAQ，量表评估理财、购物等复杂活动，其中FAQ对轻度认知损害及早期痴呆尤为敏感。评估时优先采用知情者/代理报告，确保客观性，可辅以基于表现的客观测试。

Measure time point of outcome：

The baseline will be evaluated once a year, and this will be done for a total of five years

Measure method：

During the follow-up period, the FAQ and scales were used annually to assess complex activities such as financial management and shopping. Among them, the FAQ was particularly sensitive to mild cognitive impairment and early dementia. At the time of assessment, the reports from informants/agents were given priority to ensure objectivity, and objective tests based on performance could also be used as supplementary methods.

指标中文名：

OSA严重程度、低氧负荷及其他睡眠表型

指标类型：

次要指标

Outcome：

Severity of OSA, hypoxia load, and other sleep phenotypes

Type：

Secondary indicator

测量时间点：

基线及随访期间每年评估一次，随访5年

测量方法：

在神经心理评估完成后1周内进行便携式睡眠监测。监测前一晚要求受试者避免摄入咖啡因、酒精及镇静类药物，并保持日常作息。睡眠监测采用便携式睡眠仪进行。对于MRI子队列，需完善睡眠中心PSG监测，佩戴腕表式可穿戴设备，对日常生活方式进行连续记录，包括活动水平、睡眠–觉醒节律及昼夜活动模式等指标。

Measure time point of outcome：

The baseline will be evaluated once a year, and this will be done for a total of five years

Measure method：

Portable sleep monitoring was conducted within one week after the neuro-psychological assessment. The night before the monitoring, the subjects were required to avoid caffeine, alcohol and sedative drugs, and maintain their regular daily routine. The sleep monitoring was carried out using a portable sleep device. For the MRI sub-cohort, PSG monitoring at the sleep center was necessary, and wrist-worn wearable devices were worn to continuously record daily activities, including activity levels, s

指标中文名：

脑结构改变、脑小血管病变及脑功能网络异常等影像学指标

指标类型：

次要指标

Outcome：

Imaging indicators such as brain structural changes, cerebral small vessel lesions, and abnormal brain functional networks

Type：

Secondary indicator

测量时间点：

基线及基线后第五年

测量方法：

所有MRI子队列参与者将在基线阶段接受多模态脑MRI扫描、脑灌注成像、脑电图等，构建反映睡眠神经活动与脑血流/脑网络状态协同变化的神经血管耦合表型指标。

Measure time point of outcome：

Baseline and the fifth year after baseline

Measure method：

All participants in the MRI sub-cohorts will undergo multimodal brain MRI scans, cerebral perfusion imaging, electroencephalography, etc. at the baseline stage, to construct neurovascular coupling phenotypic indicators that reflect the coordinated changes in sleep neural activity and cerebral blood flow/cerebral network status.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血

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：

标本中文名：

粪便样本

组织：

Sample Name：

Stool sample

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 45 岁 years
最大 Max age 75 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:

不公开/Private

盲法：

无

Blinding：

None

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）：

根据中国临床试验注册中心关于推进共享临床试验原始数据的公告，本研究将通过临床试验公共管理平台ResMan（www.medresman.org）上传数据，公众可在该平台浏览原始数据，但如需下载则必须直接联系研究者，由研究者经伦理委员会批准后提供，且不得泄露参试者隐私；研究者可以合理要求有偿使用数据以补偿成本，但不得以牟利为目的。数据最晚将在试验结束后6个月内或研究结果发表后6个月内公开共享。

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

According to the Announcement on Promoting the Sharing of Raw Data from Clinical Trials issued by the Chinese Clinical Trial Registry, this study will upload data to the clinical trial public management platform ResMan (www.medresman.org). The public can browse the raw data on this platform, but if downloading is required, they must directly contact the researchers. The data will then be provided by the researchers after approval by the ethics committee, and the privacy of participants must not be disclosed. Researchers may reasonably request a fee for data use to compensate for costs, but not for profit-making purposes. The data will be made publicly available no later than six months after the completion of the trial or within six months after the publication of the study results.

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：

公众若需获取本研究的原始数据，可通过临床试验公共管理平台 ResMan（www.medresman.org）浏览数据内容，但无法直接下载；如需下载详细数据，必须直接联系本研究的负责人提出申请，经所在伦理委员会批准后，由研究者提供数据下载，且不得泄露参试者的任何隐私信息。

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

If the public needs to access the raw data of this study, they can browse the data content through the clinical trial public management platform ResMan (www.medresman.org), but cannot download it directly; if they need to download detailed data, they must directly contact the principal investigator of this study to submit an application. After approval by the relevant ethics committee, the data will be provided by the researcher, and the privacy information of participants must not be disclosed.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-08 10:12:21
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