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.
This study is a preliminary pre-trial for a single-center, prospective, randomized, double-blind, placebo-controlled trial. The objective is to explore the effect of Guanxinning Tablet on improving coronary microcirculation. A total of 70 STEMI patients who have successfully undergone primary percutaneous coronary intervention (PPCI) will be enrolled. Regardless of whether elective complete revascularization is needed, after the IRA (infarct-related artery) is treated during PPCI, patients will be randomly assigned in a 1:1 ratio to two groups: one group will receive an immediate loading dose of 4 Guanxinning Tablets post-PPCI, followed by a maintenance dose of 4 tablets three times daily (TID) (intervention group), while the other group will receive placebo treatment (placebo group). Both groups will receive standard secondary prevention treatment for coronary heart disease. Patients in both groups will undergo cardiac magnetic resonance (CMR) examinations within 1 week after PPCI and at 6 months (±14 days) post-PPCI. Primary Endpoint: 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. Secondary Endpoints: * Change in the incidence of IMH in the IRA-supplied myocardial territory measured by CMR at 6 months. * Change in the percentage of microvascular obstruction (MVO) volume in the IRA-supplied myocardial territory measured by CMR at 6 months. * Change in the incidence of MVO in the IRA-supplied myocardial territory measured by CMR at 6 months. * Change in myocardial infarct size and percentage of myocardial edema volume measured by CMR at 6 months. * Change in left ventricular ejection fraction (LVEF) measured by echocardiography at 6 months. * Change in angina pectoris score at 6 months. ⑦ Change in traditional Chinese medicine (TCM) syndrome score for blood stasis pattern at 6 months. * Association between changes in circulating inflammatory markers (oxidized LDL, IL-6, hsCRP) and diabetes markers (HbA1c, FBG, GSP) at 6 months with coronary microcirculation status. Safety Endpoints: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Guanxinning 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
In 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.
Time frame: 6 months
incidence of IMH (%)
Change in the incidence of IMH in the IRA-supplied myocardial territory measured by CMR at 6 months.
Time frame: 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.
Time frame: 6 months
incidence of MVO (%)
Change in the incidence of MVO in the IRA-supplied myocardial territory measured by CMR at 6 months.
Time frame: 6 months
myocardial infarct size (/ventricular volume, %)
Change in myocardial infarct size (/ventricular volume,%) measured by CMR at 6 months.
Time frame: 6 months
myocardial edema volume (/ventricular volume, %)
Change in percentage of myocardial edema volume (/ventricular volume, %) measured by CMR at 6 months.
Time frame: 6 months
△LVEF (%)
Change in left ventricular ejection fraction (LVEF) measured by echocardiography at 6 months.
Time frame: 6 months
CCS Angina Classification change
Change in Canada Cardiovascular Society Angina Classification score at 6 months. Class I: Ordinary physical activity, such as walking and climbing stairs, does not cause angina. Angina occurs with strenuous, rapid, or prolonged exertion at work or recreation. Class II: Slight limitation of ordinary activity. Angina occurs on walking or climbing stairs rapidly, walking uphill, walking or stair - climbing after meals, in cold, in wind, or under emotional stress. Angina occurs on walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace. Class III: Marked limitation of ordinary physical activity. Angina occurs on walking one to two blocks on the level and climbing one flight of stairs at a normal pace. Class IV: Inability to carry on any physical activity without discomfort. Angina may be present at rest. The lowest CCS angina pectoris score is grade I, and the highest is grade IV. The higher the grade, the worse the outcome.
Time frame: 6 months
TCM blood stasis pattern score change
Change in traditional Chinese medicine (TCM) syndrome score for blood stasis pattern at 6 months. * Main Index: Fixed location of chest pain(10 score); Purple or dark - colored tongue(10); Ecchymosis and petechiae on the tongue(10); oronary angiography shows that at least one coronary artery is stenosed ≥ 75%(9); Ultrasound or angiography shows coronary artery thrombosis or intracardiac mural thrombosis(8); ②Secondary Index: Chest pain worsens at night(6); Purple - dark lips or gums(7); Varicose sublingual veins or purple - dark color(7); CAG shows that at least one coronary artery is stenosed ≥ 50% but \< 75%(6); Shortening of APTT or PT(5); ③Auxiliary Index: Dark - black complexion(2); Stringy pulse(4); CCTA or CAG shows obvious vascular calcification or diffuse lesions(3); Elevated fibrinogen (3); The maximum value is 80, the minimum is not clearly defined as it depends on the combination of positive indexes; The higher the score, the more severe the symptom as well as the outcome.
Time frame: 6 months
circulating inflammatory markers absolute change(oxidized LDL, mmol/L)
absolute changes in circulating inflammatory markers: oxidized LDL(mmol/L) at 6 months
Time frame: 6 months
circulating inflammatory markers absolute change (IL-6, pg/mL)
absolute changes in circulating inflammatory markers: IL-6(pg/mL) at 6 months
Time frame: 6 months
circulating inflammatory markers absolute change (hsCRP, mg/L)
absolute changes in circulating inflammatory markers hsCRP(mg/L) at 6 months
Time frame: 6 months
diabetes markers absolute change (HbA1c, %)
absolute changes in diabetes markers: HbA1c(%) at 6 months
Time frame: 6 months
diabetes markers absolute change (FBG, fasting blood glucose, mmol/L)
absolute changes in diabetes markers: FBG, fasting blood glucose, (mmol/L) at 6 months
Time frame: 6 months
diabetes markers absolute change of GSP, Glycated serum protein (%)
absolute changes in diabetes markers: GSP, Glycated serum protein (%) at 6 months
Time frame: 6 months
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