Common use of Inclusion Criteria Clause in Contracts

Inclusion Criteria. The inclusion criteria for this study are: · voluntarily signed the informed consent form prior to the conduct of any study specific procedures · male or female inpatients aged 18 to 75, inclusive · negative pregnancy test for all women of child-bearing potential, or surgically sterilized (i.e. tubal ligation, hysterectomy) prior to Screening, or post-menopausal for at least 1 year · acute MI defined as: · typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following: a) ischemic symptoms; b) development of pathologic Qwaves on the ECG; c) ECG changes indicative of ischemia (ST segment elevation or depression) · first anterior or inferolateral STEMI or Qwave MI (QMI Anterior: V1-V3 or V1-V4 or V1-V5 or V1-V6.QMI Inferior: L2, L3, AVF, or L2, L3, AVF+ V5, V6 or L2, L3, AVF+ V6-V9 [posterior leads]) · regional wall motion score index (at least 4 out of 16 akinetic segments) · one or more of the following: · LVEF >20% and <45% measured and calculated by 2-dimensional measurement · Biomarkers: peak CK > 2000 IU · infarct size > 25% as measured by MRI · successful revascularization with PCI within 7 days of the index MI (only safe and MRI compatible stents) · at time of application of device patient must have patent infarct related artery (XXX) and TIMI flow grade = 3