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临床试验/ITMCTR2024000206
ITMCTR2024000206尚未招募4 期

Clinical evidence-based study of Mongolian medicine Guanxintong capsule in the treatment of myocardial infarction/myocardial fibrosis

Hubei Provincial Hospital of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
尚未招募

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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