研究疾病:
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稳定性冠心病
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研究疾病代码:
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Target disease:
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stable 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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(1)验证参七养心方治疗稳定性冠心病的临床疗效,探究本方对稳定性冠心病患者血管流体力学、斑块形态学的影响,及对症状、体征、预后的改善作用。进一步优化本方对稳定性冠心病的治疗方案,为中医药治疗冠心病提供循证医学依据。
(2)为中医药治疗稳定性冠心病提供新理论和技术创新,提高北京地区冠心病中医药治疗水平,降低患者医疗负担,节省医疗资源,为首都医疗健康事业发展作出贡献。
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Objectives of Study:
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(1) To verify the clinical efficacy of Shen Qi Yang Xin Formula in the treatment of stable coronary artery disease, and to investigate the effects of this formula on vascular hydrodynamics and plaque morphology in patients with stable coronary artery disease, as well as its effects on the improvement of symptoms, signs, and prognosis. To further optimize the treatment plan of this formula for stable coronary heart disease, and to provide evidence-based medical basis for the treatment of coronary heart disease by traditional Chinese medicine.
(2) To provide new theories and technological innovations for the treatment of stable coronary heart disease with TCM, to improve the level of TCM treatment of coronary heart disease in Beijing, to reduce the medical burden of patients, to save medical resources, and to contribute to the development of medical and health care in the capital city.
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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)符合稳定性冠心病的诊断标准,且冠状动脉 CTA 或冠状动脉造
影显示至少一支主要分支管腔直径狭窄 50%-70%;
(2)近一个月内冠脉CTA示CT-FFR >0.8;
(3)符合气虚血瘀证的诊断标准;
(4)年龄 30-75 岁,无性别限制;
(5)志愿受试并签署知情同意书。
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Inclusion criteria
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(1) Meet the diagnostic criteria for stable coronary artery disease, and Coronary CTA or coronary angiography shows a 50%-70% narrowing of the lumen diameter of at least one major branch;
(2) Coronary CTA within the past month shows CT-FFR >0.8;
(3) Meet the diagnostic criteria of Qi deficiency and blood stasis;
(4) Age 30-75 years old, no gender restriction;
(5) Volunteer to be tested and sign an informed consent form.
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排除标准:
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(1)近 30 天内发生急性心肌梗死或进行过冠状动脉血运重建治疗。
(2)有下列疾病之一者:a.高血压病并经降压药物治疗后血压仍偏高者(收缩压≥160mmHg,舒张压≥100mmHg);b.严重恶性心律失常、肺心病、风心病、心肌炎、心肌病、主动脉夹层、肺栓塞等严重疾病。
(3)甲状腺功能亢进、颈椎病、胆心综合症、食道裂孔疝、神经官能症、更年期综合征等疾病相关的胸痛症状者。
(4)有严重出血风险者。
(5)血清谷丙转氨酶或血清肌酐>3 倍正常参考值上限者。
(6)患有严重血液系统疾病及恶性肿瘤者。
(7)有下列冠脉CTA禁忌症之一者:a.既往有严重的造影剂过敏反应史;b.不能配合扫描和屏气的患者;c.孕妇、哺乳期妇女或有生育要求的育龄妇女;d.临床生命体征不稳定(如急性心肌梗死、失代偿性心衰、严重的低血压等);e.严重的肾功能不全。
(8) 精神病或有认知功能障碍者。
(9) 对试验药物过敏者。
(10)最近 1 个月内参加过其他临床试验,或口服活血化瘀类中药制剂者。
(11)冠状动脉 CTA 图像不可用或质量不佳而不能进行斑块特征分析或流体动力分析的患者。
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Exclusion criteria:
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(1) Acute myocardial infarction or coronary artery revascularization treatment within the last 30 days.
(2) Those who have one of the following diseases: a. Hypertension and still high blood pressure after treatment with antihypertensive drugs (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg); b. Severe malignant arrhythmia, pulmonary heart disease, rheumatoid artery disease, myocarditis, cardiomyopathy, aortic coarctation, pulmonary embolism and other serious diseases.
(3) Those with symptoms of chest pain associated with diseases such as hyperthyroidism, ervical spondylosis, bile-cardiac syndrome, esophageal hiatal hernia, neurosis, and menopausal syndrome.
(4) Those at risk of severe bleeding.
(5) Those with serum ghrelin or serum creatinine >3 times the upper limit of normal reference value.
(6) Those with severe hematologic diseases and malignant tumors.
(7) Those with one of the following contraindications to coronary CTA: a. Previous history of severe allergic reaction to contrast media; b. Patients who are unable to cooperate with scanning and breath-holding; c. Pregnant women, lactating women, or women of childbearing age with childbearing requirements; d. Clinical signs of life are unstable (e.g., acute myocardial infarction, decompensated heart failure, severe hypotension, etc.); e. Severe renal insufficiency.
(8) Persons who are mentally ill or have cognitive dysfunction.
(9) Hypersensitivity to the test drug.
(10) Participation in other clinical trials within the last 1 month, or oral administration of blood-activating and blood-stasis-relieving herbal preparations.
(11) Patients whose coronary CTA images are unavailable or of poor quality for plaque characterization or hydrodynamic analysis.
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研究实施时间:
Study execute time:
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从From
2024-08-20
至To
2026-06-30
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征募观察对象时间:
Recruiting time:
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从From
2024-08-20
至To
2026-06-30
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