Clinical Study on Cardiosplenic Concurrent TreatmentMedicine for Improving the Prognosis of Complex Coronary Artery Lesions after Percutaneous Coronary Interventio

Not Applicable

• Conditions: Coronary atery disease

• Registration Number: ITMCTR2200006130
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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;

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak VO2/kg;MET;

Secondary Outcome Measures

Name	Time	Method
High sensitivity C-reactive protein;Trimethylamine N-oxide;MACCE;HAMA;Seattle Angina scale;EQ-5D-5L;stasis syndrome score of CAD;Bleeding events;Fatigue severity Scale;