Effect of Qingre Huoxue Decoction on Clinical Outcome of Patients with Coronary Heart Disease after PCI: An Ambispective Cohort Study Based on Real-World Clinical Practice
- Conditions
- Patients with Coronary Heart Disease after PCI
- Registration Number
- ITMCTR2100004591
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Aged over 18 years;
2. It meets the diagnostic criteria of coronary heart disease;
3. Stents were implanted into the target vessels for the first time;
4. It conforms to the definition of successful PCI operation;
5. The patients voluntarily participated in this study, signed a written informed consent form, and were willing to cooperate with the follow-up.
1. Coronary heart disease should exclude myocardial ischemia, injury and necrosis caused by non-coronary atherosclerosis;
2. Those who died within 7 days after PCI;
3. With severe hepatorenal insufficiency, ALT and AST were defined as >5 ULN, and the creatinine clearance rate was less than 30mL/min;
4. Suffer from severe immunodeficiency diseases (such as HIV, etc.), malignant tumors, autoimmune diseases, severe cerebrovascular diseases, blood system diseases, etc., or other diseases that may significantly reduce life expectancy;
5. Pregnant or lactating women, mentally ill;
6. Those who did not take western medicine regularly after operation;
7. Those who participated in any drug clinical trial within 1 month before operation.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of major adverse cardiovascular events (MACCE) included cardiac death, recurrence of non-fatal myocardial infarction, stroke, revascularization of target vessels and hospitalization due to unstable angina pectoris;
- Secondary Outcome Measures
Name Time Method Echocardiography includes changes of left ventricular ejection fraction, left atrial diameter, left ventricular end-diastolic diameter, wall motion and ventricular systolic and diastolic function.;Admission rate due to heart failure;The incidence of the total number of compound end-point events;Incidence of cardiac death;Changes in laboratory indicators, including blood analysis, biochemistry, blood lipids, blood coagulation, BNP, hsCRP, glycosylated hemoglobin, etc.;Incidence of revascularization of target vessels;Incidence of in-stent thrombosis;Incidence of myocardial infarction;Incidence of ischemic stroke;Changes of cardiac function classification in Killip or NYHA;complex endpoints(Incidence of cardiac death, non-fatal myocardial infarction and stroke);All-cause mortality;Evaluation of comprehensive curative effect, evaluation of angina pectoris symptoms, evaluation of electrocardiogram and changes of TCM syndrome score;