Myocardial Infarction Clinical Trial
Official title:
Mangafodipir as an Adjunct to Percutaneous Coronary Intervention in Acute Myocardial Infarction (MANAMI)
The present feasibility study is designed to find out whether pre-treatment with the compound mangafodipir (PP-099) provides an additional reduction in myocardial infarct size in patients treated with primary percutaneous coronary intervention (PCI) during acute myocardial infarction (AMI).
Mangafodipir, manganese (Mn) dipyridoxyl diphosphate (MnDPDP) and its lipophile metabolite
Mn dipyridoxyl diethylene diamide (MnPLED), are catalytic antioxidants and iron chelators.
In preclinical studies these agents reduce oxidative stress induced injuries related to
chemotherapy of cancer and to reperfusion/reoxygenation of ischemic/hypoxic myocardium.
Accordingly, in an in vivo pig model of AMI metabolite MnPLED applied at end of ischemia and
during reperfusion reduced myocardial infarct size by 55 %. Mangafodipir most likely
activates salvage pathways and prevents lethal reperfusion injuries.
Other advantages are that mangafodipir is already approved as a contrast agent for MRI of
liver, and that the experience for more than a decade reveals a high safety with minor and
tolerable side-effects.
The present study will include 20 patients treated for their first documented AMI. They will
after admission to hospital undergo primary PCI. Reopening of an occluded coronary artery
will be preceded by iv. infusion of mangafodipir or placebo in two groups , each consisting
of 10 patients. The primary endpoint will be release to plasma of commonly accepted
biomarkers of myocardial injury (Troponin T and CK-MB) measured at admission and 6 hours
after PCI. The secondary endpoints include the accumulated release of plasma biomarkers over
48 hours and direct measurement of the final myocardial infarct size at 6-10 weeks after
PCI.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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