To evaluate and improve the safety and efficacy of hypothermia as an adjunctive therapy to percutaneous coronary intervention in patients with acute myocardial infarction.
Single-center, prospective, randomized, controlled clinical study involving at least 70 patients with up to 10 roll-in patients (for training purposes). Male and female adults presenting with acute myocardial infarction may be eligible for this research study. To qualify, patients must go to the Emergency Room within up to 6 hours of onset of chest pain, present with anterior or inferior acute myocardial infarction with elevation of the ST segment greater than 1mm in 2 or more contiguous leads in the anterior or inferior wall and be eligible for the performance of a percutaneous intervention procedure. The intervention will be intravascular hypothermia using Proteus System® as an adjunctive method to percutaneous coronary intervention, adjunct hypothermia methods and parameters. During the randomization phase, at least 70 patients who meet the eligibility criteria will be randomly assigned to the 03 hour hypothermia group (percutaneous coronary intervention + cooling), to the 01 hour hypothermia group (percutaneous coronary intervention + cooling) or to the control group (percutaneous coronary intervention only) in a 1:1:1 ratio. All patients receiving PCI + Cooling will also be randomized to groups A and B. Group A will receive 1 liter of chilled normal saline (4°C) prior to PCI/reperfusion, and Group B will not receive chilled normal saline (4°C), prior to PCI. All patients included in the randomization phase will be included in the statistical analysis. Approximately 10 Roll-in patients may be enrolled at the center (for training purpose), with anterior or inferior wall infarcts. The primary endpoint will be reduction of the infarct size (%LV), studied with cardiac magnetic resonance imaging (cMR) using late gadolinium enhancement 5 days after the AMI, and 30 days after the infarction. The secundary endpoints will be * incidence of major adverse cardiac events (MACE) or death within 30 days; * resolution of the ST segment elevation after PCI; * ejection fraction determined by cMR after 30 days. * evaluation of adverse events potentially related to hypothermia and/or endovascular cooling within 30 days. * Differences in plaquelet aggregation during cooling and rewarming.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Intravascular hypothermia as an adjunctive method to primary percutaneous coronary intervention, adjunct hypothermia methods and parameters, using Proteus® Cooling System.
Primary percutaneous coronary intervention
InCor - Instituto do Coracao - HCFMUSP
São Paulo, São Paulo, Brazil
RECRUITINGInfarct size
Reduction of the infarct size (%LV), studied with cardiac magnetic resonance imaging(cMR) using late gadolinium enhancement 5 days after the AMI, and 30 days after the infarction.
Time frame: 30 days after STEMI
Ejection fraction
ejection fraction (%) as determined cardiac resonance imaging (cMR) at 30 days after randomization.
Time frame: 30 days after STEMI
MACE
Incidence up to 30 days after randomization of major adverse cardiac events (MACE), defined as: death related to cardiac complications, recurrent AMI or need for revascularization of the target vessel.
Time frame: 30 days after STEMI
ST Segment Elevation
Resolution of the ST segment elevation (milimiters) after PCI.
Time frame: 3 hours after STEMI
Cardiac enzymes
Serial evaluation of cardiac enzymes (Troponin I - ng/mL) in order to provide a secondary measure of cell injury
Time frame: 30 days after STEMI
Composite of adverse events
Composite of adverse events, defined as: 1. All-cause mortality 2. Recurrent AMI 3. Need for revascularization of the target vessel 4. Cerebral vascular accident 5. Cardiogenic shock 6. Pulmonary embolism 7. Ventricular fibrillation 8. Vascular complications requiring surgery 9. Bleeding requiring transfusion of 2 or more units of red blood cell concentrate
Time frame: 30 days after STEMI
Device complications
Complications potentially related to the implantation or to the use of the ZOLL System (hematoma, venous puncture, vascular complications requiring surgery, bleeding, surgical wound infection, systemic infection, deep venous thrombosis, pulmonary embolism by tomography)
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Time frame: 30 days after STEMI
Cooling complications
Potential complications related to cooling (thermal discomfort, myocardial ischemia, coagulopathy, arrhythmias, hypotension and pulmonary edema).
Time frame: 30 days after STEMI
All cause mortality
All cause mortality
Time frame: 30 days after STEMI
Anterior MI
Patients with elevation of the ST segment greater than 1mm in 2 or more contiguous leads in the anterior wall (v1 to v6)
Time frame: 30 days after STEMI
03 hours versus 01 hour cooling
Comparison of three hours of cooling versus one hour of cooling regarding infarct size (%LV) as determined by study with cardiac magnetic resonance
Time frame: 30 days after STEMI