acute myocardial infarction
Conditions
Interventions
Treatment group:Basic treatment+Suxiao Jiuxin Pill (after random grouping, the sublingual loading dose was 15 pills of Suxiao Jiuxin Pill on the basis of basic treatment, and later changed to 5 pills
Control group:Basic treatment+Suxiao Jiuxin Pill Placebo (after randomization, the sublingual loading dose was 15 pills of Suxiao Jiuxin Pill Placebo on the basis of basic treatment, and later changed
Sponsors
The Second Affiliated Hospital of Tianjin University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age range from 30 to 80 years old, regardless of gender; 2) Within 3 hours of the onset of infarcted chest pain, emergency PCI treatment is planned; 3) Meets STEMI diagnostic criteria; 4) Differentiation of Traditional Chinese Medicine Syndrome into Qi Stagnation and Blood Stasis Syndrome: 5) Voluntarily sign an informed consent form. 6) Healthy subjects included: ? Gender ratio 1:1, included in all age groups between 30 and 80 years old. ? Have not taken any medication or participated in any other clinical trials within the past 3 months. ? No coronary heart disease, metabolic diseases, or other illnesses. ? Voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Suspected aortic dissection or acute pulmonary embolism; Clear mechanical complications, including ventricular septal perforation, muscle and tendon rupture, or persistent or ruptured left ventricular free wall; Severe cardiogenic shock; Uncontrolled acute left heart failure or pulmonary edema; Malignant arrhythmia that cannot be controlled by antiarrhythmic drugs. 2) Individuals with congenital heart disease, heart valve disease, aneurysm, allergic constitution, drug allergy, severe infection, and severe liver and kidney dysfunction; 3) Women of childbearing age who have a pregnancy plan within one year (defined as all women with the ability to conceive) and pregnant women; 4) Individuals who have participated in any drug clinical trial within the first three months; 5) Currently using anticoagulants; 6) Researchers determine that the patient's survival period does not exceed 6 months; 7) Severe neurological disorders (Alzheimer's disease, progression of Parkinson's syndrome), lower limb disabilities or deaf mute patients; 8) Individuals with a history of tumors or current tumors, or those confirmed by pathological examination to have precancerous lesions; 9) Through examination (physical examination, X-ray examination, B-ultrasound examination, or other means), it is found that there are malignant masses in the body, or patients with proliferative glands or adenomas with endocrine activity that affect heart or endocrine function, such as pheochromocytoma, thyroid enlargement, etc; 10) According to the researcher's judgment, the patient is unable to complete this study or comply with the requirements of this study (due to management reasons or other special reasons). 11) Exclusion criteria for healthy subjects: ? Pregnant women. ? There is a record of taking medication and participating in other clinical trials in the first three months. ? According to the researcher's judgment, the patient is unable to complete this study or comply with the requirements of this study (due to management reasons or other special reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of composite endpoint events, including MACCE, 2 years after myocardial infarction (including cardiovascular death, myocardial reinfarction, emergency coronary revascularization, stroke, heart failure, cardiogenic shock, severe arrhythmia, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of composite endpoint events including MACCE at 1 month and 1 year after myocardial infarction;2-year all-cause mortality rate;Maximum changes in myocardial injury markers (cTnI, CK, CK-MB) (peak minus baseline) and area under the curve;ECG ST segment regression and no myocardial reflow (2 hours after reperfusion, 24 hours after reperfusion, 7 days after reperfusion);Myocardial infarction area (Wanger method, Aldrich scoring method, Wikins method);Angina pectoris scale;echocardiography;NT-ProBNP;6-minute walking experiment;systemic immune inflammation index;Traditional Chinese Medicine Syndrome Scoring;Quality of Life Scale; | — |
Countries
China
Contacts
Public ContactHuang Yuhong
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed