Myocardial infarction is defined as an increase in cardiac biomarkers (preferably troponin or, if unavailable, CK-MB), as well as any one of the following:
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Unstable angina requiring unscheduled hospital admission
Unstable angina requiring unscheduled hospital admission is defined as the occurrence of either typical chest pains or new ischemic ECG changes, in combination with significant stenotic lesions on coronary angiogram (or filling defect evident on scintigram, if coronary angiography is not possible). This is equivalent to severity class II or III and clinical circumstances class B under the Braunwald classification of unstable angina (1989).
Coronary arterial revascularization (percutaneous coronary intervention, coronary artery bypass grafting) All revascularizations by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) will be included, unless already scheduled at the time of acquisition of informed consent. Such prescheduled procedures will be excluded from consideration.
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Cerebral infarction
Cerebral infarction is clinically defined as new local neurological symptoms with appropriate lesions confirmed on CT or MRI (MRA).
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Cerebral hemorrhage
Cerebral hemorrhage is clinically defined as new-onset local neurological symptoms with fresh hematoma in the cerebrum, cerebellum, and/or brain stem evident on MRI/CT scans of the head. Cerebral hemorrhage does not include cerebral infarction.
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Subarachnoid hemorrhage
Onset is characterized by sudden headache and disturbed consciousness with bleeding and hematoma in the subarachnoid cavity or blood-stained cerebrospinal fluid evident on MRI/CT scans of the head.
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Cerebrovascular reconstruction
Carotid endarterectomy, percutaneous transluminal angioplasty, stenting, bypass surgery, unless already scheduled at the time of acquisition of informed consent. Such prescheduled procedures will be excluded from consideration.
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Permanent dialysis
Patients who require permanent dialysis, unless the introduction of dialysis is clearly due to other diseases (chronic glomerulonephritis, etc.); such dialysis due to other diseases will be excluded from consideration.
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Serum creatinine increased ≥ 2-fold
Serum creatinine > 1.5 mg/dL with increase .2-fold above the value at registration, as measured in verified testing at onset or within 6 months after onset, and results from hematology and urinalysis rule out other disease (heart failure, bladder cancer, renal calculus, infection, etc.)
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Large artery disease or peripheral arterial disease (aortic dissection, mesenteric artery thrombosis, occurrence of critical lower limb ischemia [ulcers], revascularization or amputation of digit or lower limb due to obstructive arteriosclerosis)
Aortic dissection: Refers to evidence of aortic splitting on imaging (transesophageal echocardiogram, CT, MRI/MRA, etc.). Mesenteric artery thrombosis: Refers to evidence of ischemic findings in the superior mesenteric artery (mainly the origin of the artery) on abdominal ultrasound, CT, or angiogram.
Occurrence of critical lower limb ischemia [ulcers] due to obstructive arteriosclerosis, revascularization or amputation of digit or lower limb will refer to the occurrence of any of the following: Critical lower limb ischemia (Fontaine grade IV) with ulceration due to obstructive arteriosclerosis, revascularization (percutaneous transluminal angioplasty, bypass grafting), or amputation of digit or lower limb.
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Death: To be confirmed by death certificate if at all possible.
Death due to events: This category includes death due to events stipulated by endpoints in the study protocol. However, deaths will be excluded if other clear causes are identified in the relationship between the death and the event.
Total mortality: All deaths will be included. The cause of death, if other than death due to events, will be identified wherever possible.
