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Appendix 2. Study Definitions of Medical Conditions
Carotid angioplasty/stent
Angioplasty with or without placement of a stent in the right, left, or both internal
carotid arteries.
Carotid endarterectomy
Surgery on right, left, or both internal carotid arteries.
Chronic atrial fibrillation
Subject had an electrocardiogram documenting atrial fibrillation and appears to have
remained in atrial fibrillation for at least 24 hours, as indicated by a repeat
electrocardiogram or an irregularly irregular pulse.
Congestive heart failure
Subject was previously told by a physician that he or she had congestive heart failure,
or ejection fraction less than 30% established by echocardiography.
Deep vein thrombosis
Subject was previously told by a physician that he or she had at least one blood clot in
at least one leg.
Diabetes mellitus
Documented physician diagnosis of diabetes mellitus and treatment with oral
hypoglycemic agent or insulin; or casual plasma glucose  200 mg/dL (11.1 mmol/L)
or fasting plasma glucose  126 mg/dL ( 7.0 mmol/L).
Hyperlipidemia
Subject is taking cholesterol-lowering medication or has a fasting serum cholesterol
level of  240 mg/dL or a fasting LDL cholesterol concentration of > 160 mg/dL.
(Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in
Adults. Executive summary of the third report of the National Cholesterol Education
Program [NCEP] Expert Panel on Detection, Evaluation, and Treatment of High
Blood Cholesterol in Adults [Adult Treatment Panel III]. JAMA 2001;285:24862497.)
Hypertension
Taking antihypertensive medication; or not taking antihypertensive medication and
having a systolic blood pressure of greater than 140 mm Hg or a diastolic blood
pressure of greater than 100 mm Hg. (The sixth report of the Joint National
Committee on Prevention, Detection, Evaluation, and Treatment of High Blood
Pressure. [JNC VI] Arch Intern Med 1997;157:2413-2446.)
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Migraine headache
Migraine with or without aura, according to International Headache Society criteria
(From Bartleson JD. Treatment of migraine headaches. Mayo Clin Proc
1999;74:702-708. By permission of Mayo Foundation).
Migraine Without Aura
A. At least five attacks fulfilling criteria in B, C, D, and E
B. Headache lasts 4 to 72 h if untreated or unsuccessfully treated
C. Headache has at least two of the following characteristics
1. Unilateral location
2. Pulsating quality
3. Moderate to severe intensity
4. Aggravation by walking stairs or similar physical activity
D. During headache, at least one of the following
1. Nausea, vomiting, or both
2. Photophobia and phonophobia
E. History, physical and neurologic examinations, and, if appropriate,
diagnostic tests exclude related organic disease
Migraine With Aura
A. At least two attacks that fulfill criteria in B and C
B. At least three of the four following characteristics
1. One or more fully reversible aura symptoms indicating focal cerebral
cortical or brain-stem dysfunction (or both)
2. At least one aura symptom develops gradually over > 4 min or two or
more symptoms occur in succession
3. No single aura symptom lasts > 60 min
4. Headache begins during aura or follows aura with a symptom-free
interval of 60 min (headache may begin before or with aura)
C. History, physical and neurologic examinations, and, if appropriate,
diagnostic tests exclude related organic disease
Myocardial infarction
Subject was previously told by a physician that he or she had a myocardial infarction.
Paroxysmal atrial fibrillation
Electrocardiogram documented atrial fibrillation in the past but subject no longer
appears to have atrial fibrillation as indicated by a repeat electrocardiogram or a
regular pulse.
Peripheral vascular disease
History of intermittent claudication or history of surgery involving any femoral or
iliac artery for an indication other than repair of a traumatic laceration.
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Pulmonary embolus
Subject was previously told by a physician that he or she had at least one pulmonary
embolus.
Recent cigarette smoking
Smoking any number of cigarettes within the past 30 days.
Remote cigarette smoking
Smoking any number of cigarettes  30 days ago, but not within the past 30 days.
Transient ischemic attacks (TIAs)
Brief episodes of focal loss of brain function, thought to be due to ischemia, that can
usually be localized to that portion of the brain supplied by one vascular system (left
or right carotid or vertebrobasilar system) and for which no other cause can be found.
(Special report from the National Institute of Neurological Disorders and Stroke:
Classification of cerebrovascular diseases III. Stroke 1990;21:637-676.) By
convention, episodes lasting less than 24 hours are classified as TIAs, although the
longer the episode, the greater the likelihood of finding a cerebral infarct by computed
tomography or magnetic resonance imaging. TIAs commonly last 2 to 15 minutes
and are rapid in onset (going from no symptoms to maximal symptoms in < 5
minutes, and usually in < 2 minutes). Fleeting episodes lasting only a few seconds are
not likely to be TIAs. A TIA leaves no persistent deficit, and there are often multiple
attacks.