CARESS in Acute Myocardial Infarction

All patients with ST-segment elevation AMI admitted within 12 hours from symptoms onset will be screened to enter in this study. Data of patients with ST-segment elevation AMI within 12 hours from symptoms onset who do not meet the inclusion criteria or do not sign the informed consent form are entered into a dedicated registry.

Inclusion criteria

• ECG with ST-elevation (≥ 1mm in at least 2 ECG limb leads or ≥ 2 mm in 2 contiguous precordial leads) AMI within <12 hours from symptoms onset fulfilling 1 or more of the following criteria of "high risk":

• Summation of ST-segment elevation or depression ≥ 15 mm in all 12 electrocardiographic leads or new onset complete left bundle branch block;
• Previous myocardial infarction (Q- and non Q-wave);
• Killip Class 2 or 3;
• LV ejection fraction at transthoracic ultrasound < 40%.

Exclusion criteria

• Inability to provide informed consent;
• Age > 75 years
• CABG or PCI procedure in past history involving the infarct-related artery;
• Participation in another study with any investigational drug or device within the previous 30 days;
• Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer);
• Cardiogenic shock (hypotension with Systolic Blood Pressure (SBP) < 90 mmHg and tachycardia > 100 beats / min, not due to hypovolemia and requiring inotropic support or balloon counterpulsation);
• Need for concomitant major surgery (e.g. valve surgery or resection of aortic or left ventricular aneurysm, carotid endarterectomy, abdominal aortic aneurysm surgery, congenital heart disease etc);
• Severe hepatic disease;
• Patients with acute or chronic renal impairment (serum creatinine > 2.0 mg % or 200 mg/l or creatinine clearance < 30 ml/min);
• Transmural MI in different location within the previous week;
• Previous administration of thrombolytics within 7 days;
• Intolerance or contraindications to ASA or Clopidogrel;
• Known leucopenia, defined as a leukocyte count of < 3.500 White Blood Cells (WBC)/ml
• Known neutropenia, defined as < 1000 neutrophils / ml;
• Known thrombocytopenia (< 100.000 platelets / ml );
• Documented active peptic ulcer or upper gastrointestinal bleeding within the previous 6 months;
• Previous hemorrhagic stroke;
• Previous ischemic cerebrovascular event within 3 months;
• Intracranial neoplasm;
• Recent major surgery at risk of bleeding;
• Episodes of uncontrolled hypertension (> 180/110 mmHg despite treatment) in past 2 years;
• Administration of oral anticoagulants within the previous 7 days unless INR ≤ 1.2;
• Severe recent trauma;
• Known or possible pregnancy;
• Absence of suitable vascular access (diffuse peripheral arterial disease);
• Basal ECG changes which make identification of ST-segment elevation impossible (i.e.: ventricular activation from artificial pacemaker, etc.).