This study aims to evaluate whether perioperative use of Shenfu Injection, as compared to placebo, could reduce infarct size assessed by cardiac magnetic resonance (CMR) in patients with acute anterior ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).
Shenfu injection is a traditional Chinese medicine formulation containing ginseng (Panax; family: Araliaceae) and aconite (Radix aconiti lateralis preparata, Aconitum carmichaeli Debx; family: Ranunculaceae) with Ginsenosides and aconite alkaloids as the main active ingredients. Its quality is strictly controlled in compliance with the standard of the China Ministry of Public Health (official approval code: certification number Z20043117; No. 110804, Ya'an, China). Animal studies have shown that Shenfu injection has protective effects against reperfusion injury through multiple pharmacologic effects, including scavenging free radicals, inhibiting inflammatory mediators, suppressing cell apoptosis, and inhibiting calcium overload. However, few data are available regarding its efficacy in humans. We aimed to determine whether perioperative use of Shenfu injection, as compared to placebo, might reduce infarct size in patients with STEMI undergoing primary PCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
326
80ml Shenfu Injection + 70ml 5% glucose injection, ivdrip, within 30 minutes before PCI and 1 to 5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.
150 ml 5% glucose injection, ivdrip, within 30 minutes before PCI and 1 to 5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
RECRUITINGInfarct size (% of left ventricular mass)
Infarct size was assessed by performing CMR imaging at 5±2 days after PCI
Time frame: 5±2 days after PCI
Microvascular obstruction (% of left ventricular mass)
Time frame: 5±2 days after PCI
Intramyocardial hemorrhage (% of left ventricular mass)
Time frame: 5±2 days after PCI
Area under the curve (AUC) of creatine kinase isoenzyme (CK-MB)
Time frame: Immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI
AUC of cardiac troponin I
Time frame: Immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI
Peak value of CK-MB and cTnI
Time frame: 72 hours after PCI
ST segment resolution (%) according to ECG
Time frame: 24 hours after PCI
TIMI flow grade
Time frame: Immediately after PCI
Corrected TIMI frame count (CTFC)
Time frame: Immediately after PCI
TIMI myocardial perfusion grade (TMPG)
Time frame: Immediately after PCI
Myocardial salvage index
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 5±2 days after PCI
Area at risk (myocardial edema, % of left ventricular mass)
Time frame: 5±2 days after PCI
Left ventricular end-diastolic volume (LVEDV)
Time frame: 5±2 days after PCI
Left ventricular end-systolic volume (LVESV)
Time frame: 5±2 days after PCI
Left ventricular ejection fraction (LVEF)
Time frame: 5±2 days after PCI
Major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergency revascularization)
Time frame: 30 days after PCI
Individual events (including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergency revascularization, re-hospitalization for heart failure)
Time frame: 30 days after PCI