Evaluation and Prognosis of Cerebrovascular and Neurological Health Status in Patients With Coronary Heart Disease After Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of brain function connectivity before and after operation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed coronary heart disease or risk of coronary heart disease through clinical testing
- •Conscious and capable of completing neuropsychological scales
排除标准
- •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.
结局指标
主要结局
Change of brain function connectivity before and after operation
时间窗: before operation; 3-10 Days after operation; 1 month; 6-12months
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.
Change of brain volume before and after treatment
时间窗: before operation; 3-10 Days after operation; 1 month; 6-12months
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.
Change of cerebrovascular morphology before and after treatment
时间窗: before operation; 3-10 Days after operation; 1 month; 6-12months
The change of Cerebral vessel density, caliber and tortuosity, brain white matter hyperintensity lesion count
次要结局
- 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 Digit Symbol Coding score(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 episodic memory functions before and after operation evaluated by Auditory Verbal Learning test(before operation; 3-10 Days after operation; 1 month; 6-12months)
- Change of serum marker concentration 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)
- Change of working memory before and after operation evaluated by Backward Digit Span(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 B(before operation; 3-10 Days after operation; 1 month; 6-12months)
研究者
Qianyan Liu
Principal Investgator
Nanjing University of Traditional Chinese Medicine