Modifiable Risk Factors for Cognitive Dysfunction in Patients With Coronary Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
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
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
2,352 Participants
are grouped into 1 trial groupGroup A: CHD Patients with Cognitive Assessment Cohort
Trial outcomes
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).
Time frame
2026-2031Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov