The current study aims to evaluate different doses of PC-SOD injections for efficacy and safety in comparison to placebo, in order to provide a basis for future clinical trials in terms of experimental design and dose selection.
The study is a randomized, single-blind, multi-center, placebo-controlled trial to preliminarily evaluate the efficacy and safety of PC-SOD, and to provide a basis for dose selection in the next stage of study. For each participant, the trial will be divided into the screening/treatment (screening and treatment conducted during the first visit, 0 d) and safety follow-up (1 - 30 d) stages. The study will screen 120 eligible subjects. After successful screening, the subjects will be randomly assigned into four groups of equal size, including the 40 mg PC-SOD, 80 mg PC-SOD, 160 mg PC-SOD and placebo control groups. Subjects in each group will be administered the corresponding intervention, followed by PCI treatment. During the safety follow-up stage, the subjects will receive basic treatment based on Guidelines for Management of Patients with ST-segment elevation myocardial infarction. Treatments will include dual anti-platelet therapy, beta-blockers, ACEI/ARB (angiotensin-converting enzyme inhibitor/ angiotensin receptor blocker), statins, anticoagulants, and so on. By comparing the efficacy and safety endpoints of patients in the experimental and placebo control groups, the study aims to preliminarily evaluate the efficacy and safety of different doses of PC-SOD in reducing myocardial reperfusion injury.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
NOT_YET_RECRUITINGZhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe myocardial salvage index at 7 d after PCI
The myocardial salvage index is defined as (area of myocardial edema - area of myocardial infarction)/area of myocardial edema.
Time frame: 7 days
The area of myocardial infarction at 7 d after PCI (detected by delayed-enhanced MRI [Magnetic Resonance Imaging] )
The area of myocardial infarction is defined as the percentage of left ventricular myocardium occupied by delayed enhancement.
Time frame: 7 days
Area of microvascular occlusion at 7 d after PCI
Microvascular occlusion is defined as the area with no enhancement in the infarcted regions where delayed enhancement can be observed on MRI scans.
Time frame: 7 days
The area of infarction determined by the AUC (area under curve) for CK-MB (creatine kinase-muscle/brain) at 72h after PCI.
The area of infarction at 72h after surgery will be roughly estimated by calculating the AUC for CK-MB (before operation, and at 6, 12, 24, 48 and 72h after operation, respectively).
Time frame: 72 hours
Cardiac function at 7 d after PCI
Cardiac function is assessed by assessing the left ventricular ejection fraction (percentage of stroke output to end-diastolic volume).
Time frame: 7 days
The TIMI (thrombolysis in myocardial infarction) grade of coronary blood flow after PCI.
Coronary artery reperfusion will be assessed by the TIMI grading system, whose grades include: Grade 0: no contrast filling at the occlusion site and distal end; Grade 1: the contrast passes some of the occluded sites, but cannot fill the distal vessels; Grade 2: the contrast can fill the distal end of coronary artery completely, but the filling and clearing of contrast is slower than that of normal coronary artery; Grade 3: the contrast can fill the distal end rapidly and completely, and can be removed quickly. The TIMI flow grades will be determined by two physicians separately. In case of disagreement, a lead physician will help make the final call.
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Time frame: within 24 hours
The corrected TIMI frame count (cTFC) after PCI.
The left anterior descending (LAD) artery will be analyzed in a 30º right anterior oblique view with 30º cranial angulation. The left circumflex (LCX) will be analyzed in a 30º right anterior oblique view with 30º caudal angulation. The right coronary artery (RCA) will be analyzed in a 45º left anterior oblique view.
Time frame: within 24 hours
TIMI myocardial perfusion grade (TMPG) after PCI
Grade 0: no contrast entering the myocardium; Grade 1: the contrast enters myocardium slowly, with myocardial staining not disappearing or lasting for more than 30 s in the targeted vessels; Grade 2: delayed entering and disappearing of contrast in the myocardium, exceeding 3 cardiac cycles; Grade 3: normal entering and disappearing of contrast in the myocardium, occurring within 3 cardiac cycles.
Time frame: within 24 hours
Percentage of ST-segment resolution on ECG (electrocardiogram) at 90 min after PCI
ST-resolution is defined as more than 50% of resolution.
Time frame: 90 minutes
Number of cardiovascular events within 30 d after PCI
Cardiovascular events included all-cause death, cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization due to heart failure.
Time frame: 30 days
SOD (Superoxide Dismutase) activity
Change from Baseline SOD activity at 6h, 12h, 24h, 48h, 72h and 7 d after surgery.
Time frame: 0 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
Occurence of adverse events
Occurence of adverse events
Time frame: During patient hospitalization, up to 30 days
Cardiac function at 30 d after PCI
Cardiac function is assessed by assessing the left ventricular ejection fraction (percentage of stroke output to end-diastolic volume).
Time frame: 30 days