Acute Myocardial Infarction
Conditions
Interventions
Single Dose Group:Standard secondary preventive drug treatment+Qishen Yiqi drop pills 0.52g (1 bag)/time+placebo 0.52g (1 bag)/time, 3 times a day
Double Dose Group:Standard secondary preventive drug treatment++Qishen Yiqi dropping pills 1.04g (2 bags)/time, 3 times a day
Control Group:Standard secondary preventive drug treatment+placebo 1.04g (2 bags)/time, 3 times a day
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent; 2. Male or female, age = 18; 3. For clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI), according to China's 2019 Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction and the fourth edition of the "Global Definition of Myocardial Infarction" standard, myocardial infarction refers to acute myocardial injury (serum cardiac troponin (cTn) increases and/or decreases, and is higher than the upper limit of the normal value at least once (99 percentile value of the upper limit of the reference value), There is also clinical evidence of acute myocardial ischemia, including: (1) symptoms of acute myocardial ischemia; (2) New ischemic ECG changes; (3) New pathological Q wave; (4) New imaging evidence of loss of viable myocardium or abnormal segmental motion of ventricular wall; (5) Coronary artery thrombosis was confirmed by coronary angiography or intracavitary imaging or autopsy. 4. Clinically, it meets the indication of emergency revascularization and the patient agrees to undergo emergency interventional treatment.
Exclusion criteria
Exclusion criteria: 1. There are contraindications for the use of Qishen Yiqi Dropping Pill: it is forbidden for those who have allergic reactions to this product; 2. There are contraindications of ACEI/ARB, statin, antiplatelet and other drugs; 3. Severe liver and kidney dysfunction; 4. Unable to tolerate standard antithrombotic therapy; 5. Life expectancy is less than half a year; 6. Those who cannot accept MRI examination for various reasons; 7. Nicorandil, other traditional Chinese medicine and traditional Chinese patent medicines and simple preparations have been used; 8. Pregnant and lactating women, women of childbearing age who have not taken contraceptive measures with drugs or instruments, or women with positive urine pregnancy test (urine chorionic gonadotropin [HCG] test); 9. People who have participated in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of myocardial fibrosis measured by MRI at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference of infarct size, microcirculation occlusive and reperfusion hemorrhage measured by MRI at 1 week;Changes and differences of infarct size, microcirculation occlusive and reperfusion hemorrhage measured by cardiac MRI at 6 months;Changes and differences of LVEF, LVEDV and LAV measured by cardiac MRI at 6 months;1. Changes and differences of ventricular septal thickness, left ventricular free wall thickness, left ventricular mass, LVEF and long-axis strain measured by echocardiography after 1 month & 6 months;Changes and differences of E/e ', E/A, E peak deceleration time (DT), E', left atrial volume and pulmonary artery systolic pressure measured by echocardiography at 1 month and 6 months;6-minute walking test, EQ-5D score and NYHA cardiac function grading at 1 month and 6 months; | — |
Countries
China
Contacts
Public ContactJianping Li
Peking University First Hospital
Outcome results
None listed