研究疾病:
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老年冠心病轻度认知障碍
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研究疾病代码:
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Target disease:
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Mild cognitive impairment in elderly with coronary heart disease
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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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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老年冠心病轻度认知功能障碍是老年共病中常见且重要的疾病群,轻度认知障碍一方面会逐步发展为痴呆,对老年人健康造成严重的影响,另一方面,合并轻度认知障碍的冠心病患者发生心血管事件风险也会增加。因此,积极探索老年冠心病合并轻度认知功能障碍患者的防治不仅能减缓共病中轻度认知障碍向痴呆的转化,同时能够降低老年冠心病患者的心血管事件发生率以及死亡率。然而,目前国内外缺乏老年冠心病合并轻度认知功能障碍的高质量循证研究,以及尚未提出有效的防治策略。基于“心脑同治”理论,以心血管衰老和脑血管衰老的防治为切入点,针对危害老年人群的心脑重大疑难共病,开展徐凤芹教授临证经验方的多中心随机平行对照试验,获得高质量临床循证证据,探索老年冠心病轻度认知功能障碍的防治策略及其科学内涵能够为我国老年人共病防治研究提供思路和方向。
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Objectives of Study:
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Mild cognitive impairment in elderly coronary heart disease (CHD) is a common and important disease group in the co-morbidities of the elderly. On the one hand, mild cognitive impairment will gradually develop into dementia, which will have a serious impact on the health of the elderly, and on the other hand, the risk of cardiovascular events will be increased in CHD patients with combined mild cognitive impairment. Therefore, actively exploring the prevention and treatment of elderly patients with coronary heart disease combined with mild cognitive dysfunction can not only slow down the transformation of mild cognitive impairment to dementia in co-morbidities, but also reduce the incidence of cardiovascular events as well as the mortality rate of elderly patients with coronary heart disease. However, there is a lack of high-quality evidence-based studies on mild cognitive impairment in elderly patients with CHD and effective prevention and treatment strategies have not yet been proposed. Based on the theory of "treating the heart and brain at the same time", taking the prevention and treatment of cardiovascular aging and cerebrovascular aging as the entry point, and targeting the major difficult cardiovascular and cerebrovascular co-morbidities endangering the elderly, we conducted a multi-center randomized, parallel-controlled trial of Prof. Xu Fengqin's empirical prescription to obtain high-quality clinical evidence and to explore the prevention and treatment strategy of mild cognitive dysfunction in elderly coronary heart disease. The study will explore the prevention and treatment strategy of mild cognitive dysfunction in elderly coronary heart disease and its scientific connotation, which can provide ideas and directions for the research on the prevention and treatment of co-morbidities in elderly people in China.
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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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(1) 符合2023 AHA/ACC/ACCP/ASPC/NLA/PCNA慢性冠状动脉疾病患者管理指南:美国心脏协会/美国心脏病学会临床实践指南联合委员会的报告中冠心病的诊断标准[17];轻度认知功能障碍诊断标准:参考中国2018年《中国痴呆与认知障碍诊治指南》:轻度认知障碍的诊断与治疗[18]诊断标准:①Moca评分18~25分;②临床痴呆评定量表(CDR)得分为 0 或 0.5 分;参照《中药新药临床研究指导原则》[19]及肾虚血瘀证诊断标准[20],拟定老年冠心病MCI肾虚血瘀证中医证候诊断标准。
(2) 年龄≥65岁且≤80岁,性别不限;
(3) 符合肾虚血瘀证辨证标准;
(4) 视觉及听觉分辨力相对完好,能够配合完成相关测评;
(5) 同意参加研究,患者本人签署知情同意书;
(6) 未参加其他临床试验者。
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Inclusion criteria
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(1) Meet the diagnostic criteria for coronary artery disease in the 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guidelines for the Management of Patients with Chronic Coronary Artery Disease: a report of the Joint American Heart Association/American College of Cardiology Clinical Practice Guidelines Committee;
(2) Meet the diagnostic criteria for mild cognitive impairment: refer to China's 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Impairment: Diagnostic Criteria for the Diagnosis and Treatment of Mild Cognitive Impairment;
(3) To formulate the diagnostic criteria for TCM symptoms of elderly coronary heart disease MCI with renal deficiency and blood stasis with reference to the "Guidelines for Clinical Research of New Chinese Medicines" and the diagnostic criteria for renal deficiency and blood stasis, and to meet the diagnostic criteria for renal deficiency and blood stasis;
(2) Age ≥65 and ≤80 years old, gender is not limited;
(3) Visual and auditory discrimination is relatively intact, and they are able to cooperate in completing the relevant assessments;
(4) Agree to participate in the study and sign the informed consent form;
(5) Not participating in other clinical trials.
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排除标准:
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(1) 诊断为 DSM-IV 痴呆诊断标准的各种原因痴呆,包括 AD、VaD,或其他类型痴呆,如帕金森病、亨廷顿病、正常压力脑积水 脑肿瘤、进行性核上性麻痹、癫痫、慢性硬膜下血肿及多发性硬化,有严重头外伤史伴持续神经功能缺损或已知的脑结构异常。
(2) 既往精神异常、先前 5 年内有药物或酒精滥用或依赖者。
(3) 试验前1个月内服用具有补肾益精作用的中药、抗胆碱药、抗惊厥药、抗帕金森药、兴奋性药、胆碱能药、抗精神病药,如服用多奈哌齐、卡巴拉汀、加兰他敏、石杉碱甲的患者。
(4) 严重肝肾功能不全者,如 ALT 或 AST 在正常值 1.5 倍以上,或血清 Cr 正常值上限以上,凝血功能障碍等预计不能完成试验患者。
(5) 曾对试验用药过敏者、服药不耐受者。
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Exclusion criteria:
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(1) Dementia of all causes with a diagnosis of DSM-IV diagnostic criteria for dementia, a history of severe head trauma with persistent neurologic deficits or known structural brain abnormalities;
(2) A history of psychiatric abnormalities, drug or alcohol abuse or dependence within the prior 5 years;
(3) Patients taking Chinese herbal medicines with tonic effects, anticholinergics, anticonvulsants, antiparkinsonian, excitatory, cholinergic, antipsychotics, such as donepezil, carboplatin, galantamine, and strychnine A, within 1 month prior to the trial;
(4) Patients with severe hepatic or renal insufficiency, e.g., ALT or AST more than 1.5 times the normal value, or blood creatinine or urea nitrogen more than 1.2 times the normal value range, creatinine clearance CrCl <60 mL/min, coagulation dysfunction, etc. Patients who are expected to be unable to complete the test;
(5) Patients who have been allergic to the test medication or intolerant to taking medication.
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研究实施时间:
Study execute time:
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从From
2024-08-16
至To
2025-10-01
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征募观察对象时间:
Recruiting time:
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从From
2024-08-01
至To
2024-08-15
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