Coronary Heart DiseaseNCT07657624
Modifiable Risk Factors for Cognitive Dysfunction in Patients With Coronary Heart Disease
An observational study of Coronary Heart Disease and Cognitive Impairment, Mild, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Cognitive Impairment, Mild
- How many people
- 2,352 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 1 May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, China
Chenchen Tu, Chief Physician, 15201648899, tcc2033@mail.ccmu.edu.cn
About this study
Official title: 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.
- Conditions
- Coronary Heart Disease, Cognitive Impairment, Mild
- Keywords
- Risk Factors, Cognitive Impairment, Coronary Heart Disease
- Medical subject headings
- Coronary Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CHD Patients with Cognitive Assessment Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2026-2031
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start30 Jun 2025
- Primary completion1 May 2031 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenchen Tu, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657624
- Sponsor's protocol ID
- Beijing Anzhen
- Status last verified
- Jul 2025
- First submitted
- 15 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Modifiable Risk Factors and Cognitive Function in Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT07657624
- Acronym / sponsor ID
- Beijing Anzhen
- Conditions
- Coronary Heart Disease, Cognitive Impairment, Mild
- Keywords
- Risk Factors, Cognitive Impairment, Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,352 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 1 May 2031 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHD Patients with Cognitive Assessment Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Diagnosis of coronary heart disease (meeting at least one of the following):
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive impairment
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Coronary Heart Disease
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Cognitive Impairment, Mild, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenchen Tu, Chief Physician (15201648899, tcc2033@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive impairment (time frame: 2026-2031). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.