Research on the Relationship Between Cognitive Function Changes and Cerebrovascular Health in Patients With Coronary Heart Disease
Evaluation and Prognosis of Cerebrovascular and Neurological Health Status in Patients With Coronary Heart Disease After Treatment
1 other identifier
observational
100
1 country
1
Brief Summary
The purpose of this study is to elucidate the imaging mechanisms of cognitive function changes in patients with coronary heart disease before and after surgery or conservative treatment, and to evaluate and predict the postoperative neurological function recovery and cerebrovascular health level of patients by combining serum markers and patient cardiovascular health evaluation indicators.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 8, 2023
April 1, 2023
2.7 years
April 28, 2023
April 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change of brain volume before and after treatment
The change of brain volume (mm3) are evaluated by structural 3DT1 weighted MRI. Freesurfer software is used to get the measured value of the volume.
before operation; 3-10 Days after operation; 1 month; 6-12months
Change of cerebrovascular morphology before and after treatment
The change of Cerebral vessel density, caliber and tortuosity, brain white matter hyperintensity lesion count
before operation; 3-10 Days after operation; 1 month; 6-12months
Change of brain function connectivity before and after operation
The change of brain functional connectivity intensity are evaluated by rest stage functional MRI. DPABI software based on MATLAB is used to get the measured the matrix value of functional connectivity.
before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary Outcomes (9)
Change of serum marker concentration before and after operation
before operation; 3-10 Days after operation; 1 month; 6-12months
Change of plasma marker concentration before and after operation
before operation; 3-10 Days after operation; 1 month; 6-12months
Change of cardiovascular risk factors before and after operation
before operation; 3-10 Days after operation; 1 month; 6-12months
Change of executive functions before and after operation evaluated by Trail-Making Test Part A
before operation; 3-10 Days after operation; 1 month; 6-12months
Change of working memory before and after operation evaluated by Forward Digit Span
before operation; 3-10 Days after operation; 1 month; 6-12months
- +4 more secondary outcomes
Study Arms (3)
CAD（coronary heart disease ）surgical treatment
CAD（coronary heart disease ）conservative treatment
HC （Healthy controls）
Interventions
Imaging data were collected in a strong magnetic field
Multi dimensional neuropsychological test
Eligibility Criteria
All of the patients of CAD（coronary heart disease ）surgical treatment group and CAD（coronary heart disease ）conservative treatment group are in-patients and out-patients in the cardiac surgery department from the research center. The subjects of healthy control group are recruited from community.
You may qualify if:
- Confirmed coronary heart disease or risk of coronary heart disease through clinical testing
- Conscious and capable of completing neuropsychological scales
You may not qualify if:
- Patients with other serious heart diseases (such as aortic aneurysm)
- People with uncontrolled hypertension or diabetes
- There are contraindications to MRI examination (there are metal implants in the body, such as cardiac pacemakers, metal dentures, artificial joints, non paramagnetism stents, etc.; there is claustrophobia)
- Have a history of severe stroke, epilepsy, traumatic brain injury, and transient ischemic events
- Existence of neurological and mental disorders (schizophrenia, depression, etc.), post-traumatic stress disorder, obsessive-compulsive disorder, multiple sclerosis, amyotrophic lateral sclerosis, etc
- Have a history of alcohol or drug abuse
- Those with significant organ dysfunction such as lung, liver, and kidney;
- Patients with tumor, infectious diseases, blood system disease and immune system disease;
- Currently participating in other clinical studies at the same time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanjing University of Traditional Chinese Medicinelead
- Xi'an Jiaotong Universitycollaborator
- Yuncheng First Hospitalcollaborator
Study Sites (1)
Yuncheng First Hospital
Yuncheng, Shanxi, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nengrui Guo
Yuncheng First Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investgator
Study Record Dates
First Submitted
April 28, 2023
First Posted
May 8, 2023
Study Start
May 1, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
May 8, 2023
Record last verified: 2023-04