①Research objective: In a small sample population, through the pre - experimental method, explore and evaluate the effect of Guanxinning tablets on the coronary microcirculation after primary percutaneous coronary intervention (PPCI) in patients with acute ST - segment elevation myocardial infarction (STEMI), with the change in the percentage of intramyocardial hemorrhage (IMH) in ventricular mass measured by cardiac magnetic resonance (CMR) imaging as the primary endpoint.
②Research significance: The research results of this project will provide preliminary theoretical basis and methodological support for the formal randomized controlled study on evaluating the effect of Guanxinning tablets on the coronary microcirculation after PPCI in STEMI patients. It will offer new ideas for the long - term clinical treatment of STEMI patients after PPCI, and provide important theoretical support for expanding the clinical indications of Guanxinning tablets and exploring the reasons for its improvement of cardiovascular outcomes.
Age between 18 and 80 years (gender is not restricted).
STEMI diagnosed for the first time and with an onset time within 12 hours. (According to the "Chinese Guidelines for the Diagnosis and Treatment of Acute ST - Segment Elevation Myocardial Infarction 2019" and the fourth - edition "Global Definition of Myocardial Infarction" criteria, myocardial infarction refers to acute myocardial injury [serum cardiac troponin (cTn) increases and/or decreases, and at least once is higher than the upper limit of the normal value (the 99th percentile of the upper limit of the reference value)], along with clinical evidence of acute myocardial ischemia, including: (1) Symptoms of acute myocardial ischemia; (2) New ischemic electrocardiogram changes; (3) New pathological Q - wave; (4) New imaging evidence of viable myocardial loss or abnormal wall segmental motion; (5) Coronary artery thrombosis confirmed by coronary angiography, intracavitary imaging examination, or autopsy.)
Successfully received PPCI treatment (assessed by visual inspection or quantitative coronary angiography, with residual stenosis of the target lesion < 20% after stent implantation or < 50% after simple balloon dilation, and forward TIMI blood flow ≥ grade 2).
Signed a written informed consent form.
Cardiogenic shock with poor response to vasoactive drugs; or uncontrolled acute left - heart failure or pulmonary edema; uncontrolled malignant arrhythmia.
LVEF < 40%.
Currently using nicorandil, other Chinese patent medicines, and Chinese herbal decoctions, etc.
Unable to undergo CMR examination for various reasons.
Parallel
Guanxinning Tablet(GXNT)
DrugGuanxinning Tablets (2015), an established treatment for stable exertional angina (Grades I-II) with TCM-diagnosed heart-blood stasis syndrome, demonstrates proven safety/efficacy. Its active components (e.g., tanshinone IIA, salvianolic acid B, tetramethylpyrazine) from Salvia miltiorrhiza and Ligusticum chuanxiong exert: Anti-atherosclerotic effects via: Anti-inflammation \& anti-LDL oxidation Endothelial improvement VSMC proliferation/migration inhibition Anti-platelet aggregation Microvascular protection through: Anti-apoptosis \& autophagy regulation Platelet adhesion inhibition Reduced inflammatory factor release
Placebo
DrugIn this study, the placebo used in the placebo control group was completely consistent with the Guanxinning Tablets (GXNT) used in the experimental group in terms of appearance, including color, shape, size, gloss, odor, bitterness, dissolution rate, and packaging.
△IMH volume (%)
The change in the percentage of intramyocardial hemorrhage (IMH) volume relative to ventricular volume in the IRA-supplied myocardial territory, measured by CMR at the 6-month follow-up.
incidence of IMH (%)
Change in the incidence of IMH in the IRA-supplied myocardial territory measured by CMR at 6 months.
△MVO volume (%)
Change in the percentage of microvascular obstruction (MVO) volume in the IRA-supplied myocardial territory measured by CMR at 6 months.
incidence of MVO (%)
Change in the incidence of MVO in the IRA-supplied myocardial territory measured by CMR at 6 months.
myocardial infarct size (/ventricular volume, %)
Change in myocardial infarct size (/ventricular volume,%) measured by CMR at 6 months.
Safety Outcomes
Composite endpoint including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, ischemia-driven repeat revascularization, rehospitalization for heart failure, and any drug-related adverse reactions.
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