ST Segment Elevation Myocardial Infarction Clinical Trial
Official title:
Efficacy of Intracoronary Infusion of Different Medicine With Targeted Perfusion Catheter on Myocardial Perfusion in Patients With STEMI Undergoing Primary PCI:an Open,Prospective,Randomized,Multicenter Trial.
The study intends to evaluate the efficacy of different medicine delivering by targed perfusion catheter incoronary administration on epicardial, myocardial perfusion and clinical outcomes in STEMI patients undergoing primary PCI.
The goal of STEMI therapy is to successfully restore both epicardial blood flow and
myocardial perfusion. PCI has been documented as being the most effective method for
restoration of epicardial blood flow. However, epicardial blood flow does not necessarily
equate to myocardial perfusion; not every patient with TIMI 3 flow after successful PCI
achieves effective myocardial tissue-level perfusion. Although epicardial TIMI 3 flow could
be restored in >90% of STEMI patients undergoing PCI, normalization of myocardial perfusion
was achieved less frequently, with detrimental impacts on survival。 Currently, there are two
main methods of angiographic assessment of myocardial perfusion: TIMI myocardial perfusion
grading (TMPG), described by Gibson et al. and myocardial blush grading (MBG), described by
Van't Hof et al. These established myocardial perfusion parameters, TMPG and MBG, have been
widely used in various important trials and are reported to be highly useful in predicting
clinical outcomes. However, visual assessment of these methods is categorical, subjective,
and operator dependent. TIMI Myocardial Perfusion Frame Count (TMPFC), a novel and objective
method that measures the filling and clearance of contrast in the myocardium using
cine-angiographic frame-counting, was developed by our center to quantify myocardial tissue-
level perfusion and was proved to be a predictive value on clinical prognosis.
Currently, there are two main types of interventions to improve myocardial perfusion . One
kind is the mechanical method, which included thrombus aspiration catheter and the distal
protective devices. It has been confirmed that the mechanical method can effectively improve
epicardial and myocardial perfusion in patient with part of large vessels and high burden
thrombus. But for patients with small vessels and no obvious visual thrombus, the efficacy is
not significant.
The other kind intervention is medicine which included GP IIb/IIIa receptor antagonist ,
adenosine , sodium nitroprusside, verapamil etc. Part of the drugs have some effect but the
overall clinical efficacy is still not satisfied.
The study intends to use targeted perfusion catheter to deliver drug to the distal targeted
blood vessels. TMPFC and TMPG are applied to evaluate the efficacy of treatment with
Nicorandil versus Alprostadil on myocardial tissue-level perfusion in STEMI patients
undergoing primary PCI.
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