COOL-AMI EU Case Series Clinical Study

Inclusion criteria

• The patient is 18 years of age.
• The patient must have symptoms consistent with AMI
• MI with ST-segment elevation
• The patient is eligible for PCI.
• The expected timing of the treatment pathway for the patient will allow for at least 10 minutes of cooling with the IVTM System prior to PCI.
• The patient or patient legal representative is willing to provide written, informed consent to participate in this clinical study.

Exclusion criteria

• The patient has had a previous myocardial infarction
• The patient is experiencing cardiogenic shock
• The patient is experiencing acute pulmonary edema.
• The patient is presenting with cardiac arrest.
• The patient is presenting with Killip risk stratification class II through IV.
• The patient is presenting with Atrial Fibrillation.
• The patient has a history of a prior large myocardial infarct or an infarct in the same segment that is currently affected.
• The patient requires an immediate surgical or procedural intervention other than PCI
• The patient has an aortic dissection.
• The patient has hepatic failure.
• The patient has end stage kidney disease.
• The patient is febrile
• Known chronic Congestive Heart Failure (CHF).
• Known previous CABG.
• Known recent stroke
• Cardio-pulmonary decompensation that has occurred en route to the hospital
• Contraindications to hypothermia
• The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
• The patient has a known history of coagulopathy
• The patient is known to be pregnant
• The patient has a known hypersensitivity to antishivering medications.
• Patient has a known history of severe hepatic or renal impairment.
• The patient has an Inferior Vena Cava filter in place (IVC).
• The patient has a life expectancy of less than 1 year
• The patient has a known, unresolved history of drug use
• The patient is currently enrolled another investigational drug or device trial