Hypothermia as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction (COOL-MI InCor)

This is an interventional treatment trial for Hypothermia, Induced focused on measuring Hypothermia, Rewarming, Myocardial Infarction, Percutaneous Cornonary Intervention Read More

Inclusion Criteria:

• Patient aged > 18 years.
• The patient must have symptoms consistent with an acute myocardial infarction (chest pain, that is, pain in the arm, etc.) that do not improve with nitroglycerin, with an onset of symptoms greater than 30 minutes but less than six hours before admission to the emergency room.
• Roll-In Patients: Anterior or Inferior MI with ST-segment elevation of > 1mm in two or more contiguous anterior precordial or inferior leads.
• Randomized Patients: Anterior wall AMI with elevation of ST segment > 1mm in two or more anterior precordial contiguous leads.
• Patient must be eligible for PCI.
• The patient or the patient's legal guardian agrees to and is willing to sign the informed consent form to participate in the clinical study (for countries where appropriate).

Exclusion Criteria:

• The patient had a previous myocardial infarction.
• The patient is experiencing cardiogenic shock (systolic blood pressure (SBP) < 80 mmHg and not responsive to fluids, or SBP < 100 mmHg with vasopressors, or in need of an intra-aortic balloon - IAB).
• The patient is presenting with resuscitated cardiac arrest, atrial fibrillation or Killip risk Stratification class II through IV.
• The patient has aortic dissection or requires an immediate surgical or procedural intervention other than PCI.
• The patient has known Congestive Heart Failure (CHF), hepatic failure, end-stage kidney disease or sever renal failure (clearance < 30 ml/min/1.73m2 .
• The patient is febrile (temperature > 37.5 °) or has experienced an infection with fever in the last 5 days.
• The patient has known previous CABG.
• The patient has known recent stroke within 90 days of admission.
• Cardiopulmonsary decompensation that has occurred en route to the hospital or in the opinion of the physician that is imminent or likely to occur following presentation to the clinical site.
• Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis 9e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans.
• The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast [agents], which cannot be adequately pre-medicated.
• The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia or sickle cell anemia, or will refuse blood transfusion.
• The patient is < 1.5 m (4 feet 11 inches) tall.
• The patient has a known hypersensitivity to buspirone hydrochloride or meperidine and/or was treated with a monoamine oxidase inhibitor in the last 14 days.
• The patient has a known history of severe hepatic or renal failure, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy or urethral stricture, that in the opinion of the physician, would be incompatible with the administration of pethidine/meperidine.
• The patient has an Inferior Vena Cava filter in place (IVC).
• The patient has a pre-MI life expectancy < 1 year due to underlying medical conditions or pre-existing morbidities.
• The patient has a known, unresolved history of drug use or alcohol dependency, or is not able to comprehend or follow the instructions.
• The patient is currently enrolled in another investigational drug or device trial that has not completed the primary endpoint. (Note: For the purpose of this protocol, patients involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial).
• The patient is apprehensive about or unwilling to undergo the required MRI imaging at follow-up, has a documented or suspected diagnosis of claustrophobia, or has Gadolinium allergy, or is in permanent Atrial Fibrillation.
• The patient has received thrombolytic therapy en route to the hospital
• The patient shows clinical evidence of spontaneous reperfusion as observed symptomatically and/ or from ECG findings (partial or complete ST resolution in ECG before randomization) upon admission
• The patient is a vulnerable subject, for instance, a person in detention (i.e., prisoner or ward of the state)
• The patient is a female who is known to be pregnant.