Clinical trial NCT05848934: Research on the Relationship Between Cognitive Function Changes and Cerebrovascular Health in Patients With Coronary Heart Disease
Official title: Evaluation and Prognosis of Cerebrovascular and Neurological Health Status in Patients With Coronary Heart Disease After Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Heart Disease
Image
Keywords: Coronary Heart Disease
MRI Imaging
Neuropsychological assessment
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Xi'an Jiaotong University
name: Yuncheng First Hospital
First posted: 2023-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: The focus of this study is to elucidate the impact of coronary heart disease on the morphology and cognitive changes of cerebral blood vessels in patients. Record imaging data, neuropsychological cognitive scales, serum markers, adverse cardiac events, and patient evaluation indicators before and after clinical treatment and follow-up period, and explore relevant factors affecting changes in cerebrovascular morphology and cognitive function.

Eligibility criteria: Inclusion Criteria:

* Confirmed coronary heart disease or risk of coronary heart disease through clinical testing
* Conscious and capable of completing neuropsychological scales

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of brain volume before and after treatment
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of cerebrovascular morphology before and after treatment
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of brain function connectivity before and after operation
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary outcomes:
measure: Change of serum marker concentration before and after operation
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of plasma marker concentration before and after operation
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of cardiovascular risk factors before and after operation
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of executive functions before and after operation evaluated by Trail-Making Test Part A
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of working memory before and after operation evaluated by Forward Digit Span
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of working memory before and after operation evaluated by Backward Digit Span
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of executive functions before and after operation evaluated by Trail-Making Test Part B
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of executive functions before and after operation evaluated by Digit Symbol Coding score
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of episodic memory functions before and after operation evaluated by Auditory Verbal Learning test
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
Other outcomes:
Locations:
city: Yuncheng
country: China
facility: Yuncheng First Hospital
state: Shanxi
Study officials:
affiliation: Yuncheng First Hospital
name: Nengrui Guo
role: PRINCIPAL_INVESTIGATOR
References: