Research on the Relationship Between Cognitive Function Changes and Cerebrovascular Health in Patients With Coronary Heart Disease

Coronary Heart Disease Clinical Trial

Official title:

Evaluation and Prognosis of Cerebrovascular and Neurological Health Status in Patients With Coronary Heart Disease After Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05848934
• Other study ID #: 82071993-1
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Nanjing University of Traditional Chinese Medicine
• Contact: Nengrui Guo
• Phone: 0086-17635599999
• Email: 657040251[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Image
• Myocardial Ischemia

Intervention

Device:
• magnetic resonance image
Imaging data were collected in a strong magnetic field

Diagnostic Test:
• Neuropsychological scale
Multi dimensional neuropsychological test

Locations

Country	Name	City	State
China	Yuncheng First Hospital	Yuncheng	Shanxi

Sponsors (3)

Lead Sponsor	Collaborator
Nanjing University of Traditional Chinese Medicine	Health Science Center of Xi'an Jiaotong University, Yuncheng First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change of serum marker concentration before and after operation	The change of serum marker concentration is evaluated by inflammatory cytokine.	before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary	Change of plasma marker concentration before and after operation	The change of plasma marker concentration is evaluated by neurofilament light chain(NFL) protein extracted from plasma.	before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary	Change of cardiovascular risk factors before and after operation	The change of cardiovascular risk factors is evaluated by blood routine and patients' living habits	before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary	Change of executive functions before and after operation evaluated by Trail-Making Test Part A	The change of executive functions are first evaluated by Trail-Making Test Part A test. The minimum value is 0 , and the maximum value is 30. This test has no clear maximum and minimum values. If the test completion time exceeds 79 seconds, it means the outcome is abnormal. The higher scores mean a worse outcome.	before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary	Change of working memory before and after operation evaluated by Forward Digit Span	The change of working memory is first evaluated by Forward Digit Span. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 7.75±1.47. The higher scores mean a better outcome.	before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary	Change of working memory before and after operation evaluated by Backward Digit Span	The change of working memory is second evaluated by Backward Digit Span. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 5.36±1.91. The higher scores mean a better outcome.	before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary	Change of executive functions before and after operation evaluated by Trail-Making Test Part B	The change of executive functions are first evaluated by Trail-Making Test Part B test. The minimum value is 0 , and the maximum value is 30. This test has no clear maximum and minimum values. If the test completion time exceeds 79 seconds, it means the outcome is abnormal. The higher scores mean a worse outcome.It is a supplement to Trail-Making Test Part A, which is optional for patients who are not familiar with the English alphabetical order	before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary	Change of executive functions before and after operation evaluated by Digit Symbol Coding score	The change of executive functions are second evaluated by Digit Symbol Coding score. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 56.53 ± 20.17. The higher scores mean a better outcome.	before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary	Change of episodic memory functions before and after operation evaluated by Auditory Verbal Learning test	The change of episodic memory are evaluated by Auditory Verbal Learning test(AVLT-H).	before operation; 3-10 Days after operation; 1 month; 6-12months