Myocardial Infarction Clinical Trial
Official title:
Rapid Endovascular Catheter Core Cooling Combined With Cold Saline as an Adjunct to Percutaneous Coronary Intervention For the Treatment of Acute Myocardial Infarction
The purpose of this study is to determine whether treatment of patients suffering from ST-elevation myocardial infarction (STEMI) with 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to percutaneous coronary intervention (PCI) result in a reduction in infarct size.
Acute myocardial infarction (AMI) is the leading cause of mortality in the western world
today. Although reperfusion of the ischemic myocardium is a prerequisite for myocardial
salvage, it has been described that the reperfusion in itself may cause additional damage to
the myocardium (reperfusion injury). In the safety & feasibility trial RAPID MI-ICE we
demonstrated that treatment of patients suffering from STEMI with 1-2 liters of cold saline
and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to
PCI was feasible, safe and resulted in a 38% reduction in infarct size/myocardium at risk.
The aim of the present study is to confirm this finding in a larger multicenter trial.
The study is a randomized, controlled, evaluator blinded, multicenter trial enrolling 120
patients at ten sites.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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