Acute Myocardial Infarction Clinical Trial
Official title:
Effects of Sodium Tanshinone IIA Sulfonate on Left Ventricular Remodeling in Patients With ST-segment Elevation Myocardial Infarction Following Percutaneous Coronary Intervention
Approximately 60 patients with ST-segment elevation myocardial infarction successfully
treated with primary percutaneous coronary intervention will be enrolled and randomized to
receive the sodium tanshinone IIA sulfonate in addition to standard therapy or the same
volume/day of normal saline.
The primary endpoint is the variation in LV end-diastolic volume index (LVEDVi) assessed
with cardiac magnetic resonance imaging (MRI) at baseline and 6 months.
The primary endpoint is to determine whether sodium tanshinone IIA sulfonate could prevent
LV remodeling among patients with completely reperfused AMI after PCI, detected by 6 month
change in LVEDVi measured using cardiac MRI when compared to placebo.
Secondary endpoints will include cardiac MRI measures of variations in microvascular
obstruction, defect size, ventricular wall motion score, wall thickening, global LV ejection
fraction, ventricular volumes (LV end-systolic/ diastolic volume) and myocardial perfusion
during the same interval.
Furthermore, the investigators will determine the variation (change from baseline) of
biomarkers indicating myocardial fibrosis (PICP, PIIINP, ICTP and MMPs) and NT-ProBNP at 1
and 6 months after AMI.
Additional efficacy endpoints will include 6-minute walk test, New York Heart Association
functional classification, Seattle Angina Questionnaire score and incidence of
cardiovascular events (defined as cardiogenic death, stroke, recurrent myocardial
infarction, readmission on account of deterioration of congestive heart failure or unstable
angina, target vessel revascularization) at the 6-month follow-up will also be analyzed to
evaluate the efficacy of sodium tanshinone IIA sulfonate treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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