Impaired coronary microcirculation in diabetics
Conditions
Interventions
Expected drug treatment group:Take compound salvia miltiorrhiza dropping pills
The placebo group:Take a placebo
Sponsors
Ruijin Hospital affiliated to Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with >= 20% reduction in IMR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Seattle Angina scale;Major cardiovascular adverse events; | — |
Countries
China
Contacts
Public ContactRuiyan Zhang
Outcome results
None listed