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Modifiable Risk Factors for Cognitive Dysfunction in Patients With Coronary Heart Disease

2026年7月14日 更新者:Chenchen Tu、Beijing Anzhen Hospital

Association Between Modifiable Risk Factors and Cognitive Function in Patients With Coronary Heart Disease

This prospective observational study aims to investigate the association between risk factors and cognitive function in patients with coronary heart disease (CHD), and to explore the underlying mechanisms involving metabolic parameters and multimodal imaging features. A total of 2,352 participants will be enrolled from Beijing Anzhen Hospital, Capital Medical University, China. Eligible participants are adults (≥18 years) with confirmed CHD who undergo systematic neuropsychological assessment during hospitalization. Comprehensive assessments include cognitive function tests (MMSE, MoCA, BCAT, AD8), metabolic evaluations (fasting glucose, insulin, HbA1c, ceramides), coronary computed tomography angiography (CCTA), cardiac magnetic resonance (CMR), sleep respiratory monitoring, and frailty and psychological assessments.The primary outcome is cognitive impairment. The study will identify potential risk factors and provide insights into early identification and personalized intervention strategies for cognitive decline in CHD patients.This study is led by the National Clinical Research Center for Cardiovascular Diseases and invited to be carried out by several Chinese centers including Beijing Anzhen Hospital.

研究概览

研究类型

观察性的

注册 (估计的)

2352

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Chenchen Tu, Chief Physician
  • 电话号码:15201648899
  • 邮箱:tcc2033@163.com

学习地点

    • China
      • Beijing、China、中国
        • 招聘中
        • Beijing Anzhen Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

This study population consists of 2,352 adult patients aged 18 years and older with a confirmed diagnosis of coronary heart disease (CHD) who are recruited at Beijing Anzhen Hospital, Capital Medical University. Eligible participants have documented coronary artery stenosis ≥50% on angiography or CTA, a prior CHD diagnosis with medical/interventional/surgical treatment, or objective evidence of myocardial ischemia; they must be able to complete standardized neuropsychological cognitive assessments, undergo metabolic testing and cardiac imaging (CCTA/CMR), and provide written informed consent. Patients are excluded if they have pre-existing dementia, a history of stroke or other cognitive-impairing central nervous system diseases, severe psychiatric disorders, or are pregnant/breastfeeding. This is a non-interventional, observational cohort undergoing only routine clinical evaluations to explore modifiable risk factors for cognitive impairment in CHD patients.

描述

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Diagnosis of coronary heart disease (meeting at least one of the following):

    • Coronary angiography or coronary CTA showing ≥50% stenosis in ≥1 major coronary artery;
    • Established diagnosis of coronary heart disease with prior medical, interventional, or surgical treatment;
    • Objective evidence of myocardial ischemia or typical clinical symptoms
  3. Completion of standardized neuropsychological assessment during hospitalization
  4. Completion of metabolic marker evaluation (fasting glucose, insulin, HbA1c, etc.) and agreement to undergo relevant imaging and functional assessments
  5. Provision of signed written informed consent

Exclusion Criteria:

  1. Previously diagnosed dementia.
  2. History of stroke, cerebral hemorrhage, or other central nervous system diseases known to cause cognitive impairment.
  3. Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder).
  4. Pregnancy or breastfeeding.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
CHD Patients with Cognitive Assessment Cohort

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cognitive impairment
大体时间:2026-2031
Cognitive impairment in patients with coronary heart disease, defined by standardized neuropsychological assessments including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Brief Cognitive Assessment Tool (BCAT), and Alzheimer's Disease 8-Item Screening Questionnaire (AD8), evaluated as a binary outcome (presence or absence of cognitive impairment).
2026-2031

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年6月30日

初级完成 (估计的)

2031年5月1日

研究完成 (估计的)

2031年5月1日

研究注册日期

首次提交

2026年6月15日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年7月15日

上次提交的符合 QC 标准的更新

2026年7月14日

最后验证

2025年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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