ITMCTR2024000027招募中Unknown
Clinical trial on the treatment of coronary microvascular disease with Shexiang Tongxin dropping pill
Guangdong provincial Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 35 至 75（—）
- 性别
- All
入选标准
- •1.Men or women aged 35-75
- •2.Symptoms of myocardial ischemia, including patients with stable angina pectoris and unstable angina pectoris
- •3.LVEF >50% or more confirmed by transthoracic cardiac ultrasound
- •4.Perform coronary angiography or coronary CT (MSCT) to determine that there is no >50% stenosis in the three major epicardial vessels, or prior PCI with no >50% stenosis in the original stent
- •5.Objective evidence of myocardial ischemia, such as ischemic changes on the electrocardiogram during angina episodes or ischemic changes on the electrocardiogram induced by the use of a flat-plate exercise loading test, and/or abnormal ventricular wall motion
- •6.Impaired coronary microvascular function is suggested by the use of any of the following tests:
- •a. Intracoronary pressure guidewire to detect the coefficient of microcirculatory resistance (IMR)
- •b. Selective coronary angiography suggests the phenomenon of slow coronary blood flow (TIMI flow frame count method)
- •c.Cardiac magnetic resonance imaging (CMR)
- •7. Voluntarily undergo all examinations and follow-up assessments required by the study protocol
- •8. Subjects were informed and voluntarily signed an informed consent form
排除标准
- •1. new acute myocardial infarction within 3 months
- •2. Subjects cannot tolerate dual antiplatelet therapy
- •3. Obvious hematopoietic system abnormalities, such as platelets <72 x 10^9/L or >700 x 10^9/L and white blood cells <3 x 10^9/L
- •4. Active bleeding and obvious bleeding tendency, such as active ulcers, recent ischemic stroke, history of hemorrhagic stroke, intracranial space-occupying lesions, recent craniocerebral trauma, active bleeding from other organs that cannot be easily hemostatized, or bleeding tendency
- •5. Combined with other organ failure, such as severe renal insufficiency (GFR<30ml/min/1.73m2) or severe hepatic impairment (AST or ALT elevated more than 3 times the upper limit of normal value), combined with severe congestive heart failure (cardiac function>class III). Suffering from serious diseases with a life expectancy of less than 12 months, such as malignant tumors, other diseases in advanced stages
- •6. Pregnant women and women planning a pregnancy
- •7. Acute infectious diseases
- •8. Combined immune system diseases
- •9. Subject is allergic to or has contraindications to concomitant medications required by the study protocol (e.g., aspirin, clopidogrel, statins, contrast agents, anticoagulants, nicorandil, muscimol drops, etc.)
- •10. Patients with cognitive impairment, severe hearing and visual impairment who are unable to complete pre-group communication and who refuse to be reviewed
- •11. is participating in a clinical trial of another drug or device that has not yet reached its primary endpoint, or is scheduled to participate in a clinical trial of another drug or device within 12 months after surgery
研究者
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