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临床试验/ITMCTR2200005813
ITMCTR2200005813尚未招募未知

Effect of compound Salvia miltiorrhiza dropping pills on improving coronary microcirculation disorder in diabetic patients

Ruijin Hospital affiliated to Shanghai Jiaotong University0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional study

入排标准

年龄范围
18 至 75(—)
性别
All

入选标准

  • 1) Age =18 and =75, male or female.
  • 2) The left anterior descending coronary artery microcirculation resistance index (IMR) =25 was examined by pressure guide wire.
  • 3) Have been diagnosed with type 2 diabetes or meet the diagnostic criteria for type 2 diabetes.
  • 4) Combined with chest tightness, chest pain, palpitation, shortness of breath and other typical or atypical angina symptoms.
  • 5) Coronary angiography showed no severe epicardial coronary artery stenosis (diameter stenosis rate <50%).
  • 6) The patient agrees to participate in this study.

排除标准

  • Subjects that meet any of the following criteria will be excluded from this study:
  • 1) Severe cardiac insufficiency (LVEF<40%).
  • 2) Atrioventricular block and bronchial asthma above II°.
  • (3) Malignant hypertension (SBP=200 mmHg and/or DBP=120 mmHg) or severe hypotension (SBP < 90 mmHg).
  • 4) Acute myocarditis, pericardial disease, valvular heart disease, primary cardiomyopathy, myocardial infarction, severe left ventricular hypertrophy (ventricular wall or septum thickness =13mm).
  • 5) Familial hypercholesterolemia.
  • 6) Multiple arteritis.
  • 7) Heart stenting was performed within 3 months.
  • 8) Coronary artery bypass grafting.
  • 9) History of stroke within six months, history of intracranial diseases (aneurysm, arteriovenous malformation), history of extensive trauma or surgery within six weeks;
  • 10) Active bleeding, anemia of moderate or higher severity, including known thrombocytopenia or leukopenia, severe liver or kidney dysfunction, uncontrolled infection, immune system and connective tissue diseases.
  • 11) those who are pregnant or lactation, or have the intention to give birth within one year, or take effective contraceptive measures during their childbearing years.
  • 12) Abnormal liver function (serum ALT level exceeding 3.0 times the upper limit of normal) or abnormal kidney function (eGFR=30%).
  • 13) Other respiratory, digestive, blood, infectious, immune, endocrine, neuropsychiatric, tumor and other diseases of clinical significance, which may cause serious risks to patients.
  • 14) Patients requiring warfarin or NOAC anticoagulation treatment are taking K channel opening agents and Traditional Chinese medicine preparations for promoting blood circulation and removing stasis to improve microcirculation.
  • 15) Allergic to contrast agent or CDDP;
  • 16) Life expectancy less than one year;
  • 17) Patients who participated in other TCM clinical studies within 12 months prior to inclusion.

研究者

发起方
Ruijin Hospital affiliated to Shanghai Jiaotong University

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