ITMCTR2024000206尚未招募4 期
Clinical evidence-based study of Mongolian medicine Guanxintong capsule in the treatment of myocardial infarction/myocardial fibrosis
试验速览
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
- 18 至 80(—)
- 性别
- All
入选标准
- •(1) Voluntarily participate in clinical trials and sign informed consent;
- •(2) Age 18-80 years old (including the critical value), male and female;
- •(3) meet the diagnosis of acute ST elevation myocardial infarction (STEMI);
- •(4) Patients who clinically meet the indications for emergency revascularization and agree to concurrent emergency interventional therapy (PCI);
- •(5) Patients in accordance with Mongolian medicine diagnosis and syndrome differentiation of heart tingling (coronary heart disease) and sticky heart tingling;
- •(6) Serological or imaging indicators of myocardial fibrosis suggest changes in myocardial fibrosis.
排除标准
- •(1) In addition to this disease, acute coronary syndrome (ACS) had occurred within the past 1 month;
- •(2) Patients with new cardiovascular and cerebrovascular disease within 6 months before screening and those requiring cardiac surgery within 3 months or during the trial period; Uncontrolled hypertension and blood sugar, according to the latest guidelines, refer to the criteria for hypertensive diabetes: systolic blood pressure =140mmhg and/or diastolic blood pressure =90mmhg (refer to the 2023 Chinese Guidelines for Hypertension Prevention and Treatment); If you have diabetes symptoms, add blood glucose =11.1mmol/L at any point or fasting blood glucose =7.0mmol/L or blood glucose =11.1mmol/L 2 hours after a 75g glucose load (refer to the ADA Guidelines 2024).
- •(3) Patients who cannot tolerate basic treatment such as standard antithrombotic therapy, or who cannot receive MRI examination for various reasons;
- •(4) Severe liver and kidney dysfunction (ALT > 3 times the normal value, Scr > 221µmol/L) and other serious diseases;
- •(5) Pregnant or lactating women or those who have a pregnancy plan; A suspected or clear allergy to the investigational drug;
- •(6) Use any medicine containing basically the same ingredients as this Mongolian medicine within 2 weeks;
- •(7) Subjects who have experienced thrombolysis (including PCI after thrombolysis failure);
- •(8) TIMI after PCI was less than 2.
- •Those who meet any one of the above criteria are excluded.
研究者
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