ITMCTR2200006130Not yet recruiting未知
Clinical Study on Cardiosplenic Concurrent TreatmentMedicine for Improving the Prognosis of Complex Coronary Artery Lesions after Percutaneous Coronary Intervention
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 18 to 75 (—)
- Sex
- All
Inclusion Criteria
- •(1) Diagnosed as complex coronary artery lesions, when coronary angiography includes at least one of the following conditions:
- •a.bifurcation lesions (side branch diameter>2.0mm);
- •b.excessive tortuosity of proximal segment;
- •c.severe coronary artery calcification;
- •d.chronic total occlusion lesions (>3 months);
- •e.left main lesions;
- •f.aorto-ostial lesions;
- •g.diffuse lesions (>20mm length);
- •h.multivessel coronary artery stenosis (=2 two vessels);
- •i.extremely angulated lesions(>90°bend);
- •j.in-stent restenosis.
- •(2) Diagnosed as stable angina of coronary atery disease;
- •(3) NYHA function grade I-?;
- •(4) Within 2 years after PCI, and at least one coronary stent has been implanted;
- •(5) 18 ~ 75 years old;
- •(6) Diagnosed as TCM syndrome of heart and spleen deficiency;
- •(7) The patient did not take antibiotics, hormones, laxatives, antidiarrheal drugs, and probiotics within 3 months before enrollment;
- •(8) Written informed consent is obtained.
Exclusion Criteria
- •(1) Indication of renal insufficiency with serum creatinine >220umo/l in men or >175umo/l in women;
- •(2) Severe liver disease or ALT and AST both 3 times above the upper limit of normal;
- •(3) Controlled systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg;
- •(4) Diabetic patients with random blood glucose = 13.7 mmol/L or glycosylated hemoglobin = 9.5%;
- •(5) Women who are pregnant or planning to become pregnant, or who are breastfeeding;
- •(6) Severe acute or chronic cerebrovascular disease;
- •(7) Malignancies;
- •(8) Severe hematopoietic disorders;
- •(9) Severe mental illness;
- •(10) Inflammatory or malabsorptive intestinal disorders;
- •(11) Patients who have participated within the last three months or are participating in other clinical trials;
Investigators
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