Acute Myocardial Infarction
Conditions
Interventions
The experimental group:Shexiang Baoxin Pills will be administered as a four-pill dose alongside conventional pre-PCI medication, followed by a postoperative regimen of four pills taken orally three ti
the control group:The matching placebo will be administered as a four-pill dose alongside conventional pre-PCI medication, followed by a postoperative regimen of four pills taken orally three times da
Sponsors
WEST CHINA TIFU HOSPITAL SICHUAN UNIVERSITY
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Voluntarily provide written informed consent approved by the Ethics Committee. (2)Patients diagnosed with acute myocardial infarction (AMI) who undergo emergency PCI within 12 hours of symptom onset. Diagnostic criteria for AMI are based on the Fourth Universal Definition of Myocardial Infarction, defined as follows: acute chest pain onset within 12 hours, cardiac troponin (cTn) elevation above the 99th percentile upper reference limit, and electrocardiogram (ECG) showing ST-segment elevation = 0.2 mV in two contiguous precordial leads or = 0.1 mV in two limb leads, or newly identified or presumed new left bundle branch block (LBBB). (3)Aged 18–75 years, regardless of gender. (4)Door-to-wire (D-W) time < 90 minutes, with final angiographic TIMI flow grade 2–3. (5)Patients and their families are fully informed and willing to comply with all examinations and observations specified in the trial protocol.
Exclusion criteria
Exclusion criteria: (1) History of old myocardial infarction. (2) Previous percutaneous coronary intervention or coronary artery bypass grafting. (3) Heart failure caused by other etiologies. (4) Severe cardiac arrhythmia. (5) Cardiogenic shock. (6) Pre-existing severe valvular regurgitation. (7) Severe aortic stenosis. (8) Serious complications following PCI. (9) Severe pre-existing hepatic, renal, or hematological diseases. (10) Severe mental illness, malignant tumor, or other uncontrolled systemic diseases. (11) Pregnant or lactating women. (12) Patients with allergic constitution or hypersensitivity to the investigational drug. (13) Other conditions deemed by the investigator as inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left Ventricular Ejection Fraction;Left Ventricular End-Diastolic diameter;Left Ventricular End-Systolic diameter; | — |
Secondary
| Measure | Time frame |
|---|---|
| B-type Natriuretic Peptide;6-Minute Walk Test;New York Heart Association Functional Classification;Minnesota Living with Heart Failure Questionnaire; | — |
Countries
China
Contacts
Public ContactLi Zhang
WEST CHINA TIFU HOSPITAL SICHUAN UNIVERSITY
Outcome results
None listed