研究疾病:
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冠心病
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研究疾病代码:
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Target disease:
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Coronary heart disease
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Target disease code:
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研究类型:
Study type:
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观察性研究
Observational study
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研究设计:
Study design:
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横断面
Cross-sectional
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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运用神经心理状态评价量表和心理学实验范式评估对比心气虚CHD患者和健康人的认知功能,探究CHD患者认知功能、神经影像、生物电活动改变的相关性及因果关系分析。
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Objectives of Study:
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Neuropsychological state assessment Scale and psychological experiment paradigm were used to evaluate and compare the cognitive function of heart-qi deficiency CHD patients and healthy people, and to explore the correlation and causality analysis of the changes in cognitive function, neuroimaging and bioelectrical activity of CHD patients.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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病例组纳入标准:
(1)符合心气虚证诊断标准;
(2)年龄在18-65岁之间,右利手,初中及以上学历,简易韦氏智商测试>80分,能理解并配合本研究涉及的问卷和检查;
(3)符合上述冠心病诊断标准,心功能 I~II 级,病情稳定;
(4)SCL-90量表总分<160分,且阳性项目数<43项,且任一因子分不超过2分;汉密尔顿焦虑量表(HAMD)<8分,汉密尔顿焦虑量表(HAMA)<7分,焦虑自评量表 (SAS)<50分,抑郁自评量表 (SDS)<50分;
(5)自愿参与临床研究并签署知情同意书,能理解和配合本研究。
对照组纳入标准:
(1)无器质性及显著功能性疾病,无亚健康症状表现;
(2)年龄在18-65岁之间,右利手,初中及以上学历,简易韦氏智商测试>80分,能理解并配合本研究涉及的问卷和检查;
(3) SCL-90量表总分<160分,且阳性项目数<43项,且任一因子分不超过2分;汉密尔顿焦虑量表(HAMD)<8分,汉密尔顿焦虑量表(HAMA)<7分,焦虑自评量表 (SAS)<50分,抑郁自评量表 (SDS)<50分;
(4)自愿参与临床研究并签署知情同意书,能理解和配合本研究。
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Inclusion criteria
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Inclusion criteria for case group:
(1) Meet the diagnostic criteria of heart-qi deficiency syndrome;
(2) Aged 18-65 years old, right-handed, junior high school education or above, simple Wechsler IQ test > 80, able to understand and cooperate with the questionnaire and examination involved in this study;
(3) Meet the above diagnostic criteria for coronary heart disease, grade I to II heart function, and the condition is stable;
(4) The total score of SCL-90 scale is < 160 points, and the number of positive items is < 43, and the score of any factor is not more than 2 points; Hamilton Anxiety Scale (HAMD) < 8 points, Hamilton Anxiety Scale (HAMA) < 7 points, Self-rating Anxiety Scale (SAS) < 50 points, Self-rating Depression Scale (SDS) < 50 points;
(5) Voluntarily participate in clinical research and sign informed consent, and be able to understand and cooperate with this study.
Control group inclusion criteria:
(1) No organic and significant functional diseases, no sub-health symptoms;
(2) Aged 18-65 years old, right-handed, junior high school education or above, simple Wechsler IQ test > 80, able to understand and cooperate with the questionnaire and examination involved in this study;
(3) The total score of SCL-90 scale is < 160 points, and the number of positive items is < 43, and the score of any factor is not more than 2 points; Hamilton Anxiety Scale (HAMD) < 8 points, Hamilton Anxiety Scale (HAMA) < 7 points, Self-rating Anxiety Scale (SAS) < 50 points, Self-rating Depression Scale (SDS) < 50 points;
(4) Voluntarily participate in clinical research and sign informed consent, and be able to understand and cooperate with this study.
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排除标准:
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(1)心功能 III~IV 级,或处于急性发作期,病情不稳定者;
(2)并发其他心血管疾病,如房颤、心脏瓣膜病、风心病、心肌炎等;
(3)已确诊痴呆、精神分裂症、抑郁焦虑等精神疾病者,曾有重大脑外伤史、有重大脑血管意外(脑出血、脑梗死)病史;
(4)近2周内有严重感染、有严重的肝肾功能不全、有除心血管系统以外的其他系统严重疾病、妊娠哺乳期妇女等。
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Exclusion criteria:
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Exclusion criteria for case groups:
(1) There are contraindications to MRI scanning or poor blood pressure control, SBP≥140mmHg, DBP≥90mmHg;
(2) Grade III to IV heart function, in the acute attack period, the condition is unstable;
(3) Taking drugs other than those recommended by the guidelines for the treatment of heart failure and coronary heart disease;
(4) Complicated with other cardiovascular diseases, such as atrial fibrillation, heart valvular disease, rheumatic heart disease, myocarditis, etc.
(5) Those who have been diagnosed with mental diseases such as dementia, schizophrenia, depression and anxiety, have a history of major brain trauma, and have a history of major cerebrovascular accidents (cerebral hemorrhage, cerebral infarction);
(6) In the past 2 weeks, there are serious infections, serious liver and kidney insufficiency, serious diseases of other systems except cardiovascular system, pregnant and lactating women, etc.
Control group exclusion criteria:
(1) Patients with contraindications for MRI examination;
(2) Unable to understand and cooperate with the researcher.
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研究实施时间:
Study execute time:
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从From
2024-05-31
至To
2026-03-31
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征募观察对象时间:
Recruiting time:
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从From
2024-07-16
至To
2025-08-31
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