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

NCT07657624 | Recruiting

• 1 other identifier: Beijing Anzhen
• Study Type: observational
• Target: 2,352
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Heart Disease; Cognitive Impairment, Mild

Keywords

Risk Factors; Cognitive Impairment; Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

CHD Patients with Cognitive Assessment Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years
• 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
• Completion of standardized neuropsychological assessment during hospitalization
• Completion of metabolic marker evaluation (fasting glucose, insulin, HbA1c, etc.) and agreement to undergo relevant imaging and functional assessments
• Provision of signed written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, China, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Chenchen Tu, Chief Physician

CONTACT

15201648899; tcc2033@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: June 30, 2025
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: July 15, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)