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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI
Graz University Hospital
Graz, Austria
Innsbruck University Hospital
Innsbruck, Austria
Medical University of Vienna
Vienna, Austria
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark
University Medical Centre
Ljubljana, Slovenia
Sahlgrenska University Hospital
Gothenburg, Sweden
Skane University Hospital, Lund, Sweden
Lund, Sweden
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI.
Time frame: At 4±2 days
Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in the patients who are cooled and achieve a target temperature of < 35 C prior to PCI.
Time frame: At 4±2 days
Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in patients with an occluded and non-occluded IRA before PCI.
Time frame: At 4±2 days
Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in the per protocol population who are cooled according to protocol and meet inclusion criteria.
Time frame: At 4±2 days
Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in patients with anterior or inferior myocardial infarctions separately.
Time frame: At 4±2 days
The effect of the hypothermia protocol on the incidence of death.
Time frame: 45±15 days and 6 months.
Plasma level of high sensitivity Troponin T AUC through 48 hours and peak plasma level of high sensitivity Troponin T within 48 hours after AMI.
Time frame: 48 hours
ST-segment resolution 1.5 hour after opening the IRA.
Time frame: 1.5 hours
Coronary blood flow and coronary angiography at the index event estimated by TIMI coronary flow and coronary perfusion grading.
Time frame: 2 hours
Plasma NT-proBNP levels at day 4±2.
Time frame: Day 4±2.
Incidence of death at 1, 2, 3, 4 and 5 years.
Time frame: 5 years
Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI at 6±1 months.
Time frame: 6 months
Incidence of heart failure within 45±15 days.
Time frame: 6 months
Incidence of pulmonary oedema.
Time frame: 1 week
Incidence of infections
Time frame: 1 week
Incidence of bleedings
Time frame: 1 week
The effect of the hypothermia protocol on the incidence of recurrent MI.
Time frame: 6 months
The effect of the hypothermia protocol on the incidence of emergent stent revascularisation.
Time frame: 6 months
The effect of the hypothermia protocol on the incidence of any hospitalisation.
Time frame: 6 months
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