Clinical Trial: THE REOPEN-AMI STUDY - Intracoronary Nitroprusside Versus Adenosine in Acute Myocardial Infarction
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized Evaluation Of Intracoronary Nitroprusside vs Adenosine After Thrombus-aspiration During Primary PErcutaneous Coronary Intervention for the Prevention of No Reflow in Acute Myocardial Infarc
Brief Summary:
The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in acute myocardial infarction is described in up to 40% of cases. This event is associated with a worse prognosis at follow up and an unfavourable left ventricular remodelling . Two main pathogenetic mechanisms cause no-reflow: distal embolization and ischemia-reperfusion injury.
Due to the multifactorial pathogenesis of no-reflow during acute MI a combined mechanic and pharmacologic approach is believed to offer a better solution for achieving optimal microvascular reperfusion. Thus, in this randomized study we will assess the effect of nitroprusside or adenosine in adjunct to current best therapy (thrombus aspiration and IIb-IIIa antagonists) for ST elevation MI using ST segment resolution on standard 12 leads ECG as primary endpoint of myocardial reperfusion.
Detailed Summary:
The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in acute myocardial infarction is described in up to 40% of cases. This event is associated with a worse prognosis at follow up and an unfavourable left ventricular remodelling. Two main pathogenetic mechanisms cause no-reflow: distal embolization and ischemia-reperfusion injury. Microembolization, which may be well prevented by a mechanic approach (device-based), play of course an important role in the no-reflow during primary percutaneous coronary intervention (primary PCI), however ischemia reperfusion injury is also independent of microemboli, indeed it occurs in the animal model after ligation of a non atherosclerotic coronary. Thrombus aspiration assisted primary intervention achieves complete resolution of the ST segment in 60% only of patients, whereas results of filter based studies have been substantially negative. A recent meta-analysis confirmed that thrombus aspiration improves microvascular perfusion, whereas filters do not.
Taken together available data suggest that other approach need to be tested in conjunction with the mechanical one to further improve microvascular integrity in this setting. Importantly, current antiplatelet therapy during reperfusion therapy for acute MI has not abolished the no-reflow phenomenon. Based on the experience matured in many studies of basic cardiology which investigated the model of ischemia and reperfusion various drugs have been tested in the human model.
Two drugs have emerged in particular as possible adjunct to reperfusion therapy: nitroprusside and adenosine. For the former good results have been obtained in small series, in contrast adenosine has been tested in a large randomized trial (AMISTAD-II trial) with controversial results when used at low dose. Another study using large
Sponsor: Catholic University of the Sacred Heart
Current Primary Outcome: Rate of major adverse cardiac events [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Catholic University of the Sacred Heart
Dates:
Date Received: December 31, 2007
Date Started: January 2008
Date Completion:
Last Updated: March 25, 2012
Last Verified: March 2012
