Effect of Guanxinning Tablet on Coronary Microcirculation After Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Guanxinning Tablet(GXNT)
  • Placebo

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators