NCT03252665

Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients Undergoing Primary PCI

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• ST Segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Alprostadil	alprostadil,2ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
DRUG	Nicorandil	Nicorandil,2mg, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
DRUG	Nitroglycerin	Nitroglycerin,200ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2017-08-17
• Last updated: 2017-08-17

Locations

1 site across 1 country: China