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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Heart Disease; Cognitive Impairment, Mild

• Study Type: Observational
• Enrollment (Estimated): 2352

Contacts and Locations

• Study Contact: Name: Chenchen Tu, Chief Physician; Phone Number: 15201648899; Email: tcc2033@163.com

Study Locations

• China
  • China
    • Beijing, China, China
      • Beijing Anzhen Hospital
      • Contact: Chenchen Tu, Chief Physician; Phone Number: 15201648899; Email: tcc2033@mail.ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CHD Patients with Cognitive Assessment Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive impairment	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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Risk Factors; Coronary Heart Disease
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Heart Diseases; Neurocognitive Disorders; Cognition Disorders; Myocardial Ischemia; Cognitive Dysfunction; Coronary Disease
• Other Study ID Numbers: Beijing Anzhen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No