Pilot Study of Pre-Ischemic Conditioning for Intracranial Atherosclerosis

Inclusion Criteria

• Symptomatic cerebral infarction within 30 days of enrollment attributed to 70-99% stenosis of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery, or basilar artery) that is documented by any of the following: MRA, CTA, or catheter angiography. Percent stenosis will be measured according to WASID criteria (= 1 - [Ds / Dn]) x 100% with Ds [diameter of stenosis] and Dn [diameter of normal vessel]).19
• Modified Rankin score of ≤ 3
• Age ≥ 30 years and ≤ 90 years. Subjects 30-49 years are required to meet at least one additional criteria (i-vi) provided in the table below to qualify for the study. This additional requirement is to increase the likelihood that the symptomatic intracranial stenosis in subjects 30-49 years is atherosclerotic.
• i. insulin dependent diabetes for at least 15 years
• ii. at least 2 of the following atherosclerotic risk factors: hypertension (BP > 140/90 or on antihypertensive therapy); dyslipidemia (LDL > 130 mg /dl or HDL 150 mg/dl or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was 15 mm Hg between both arms
• Known allergy to aspirin or clopidogrel
• Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115 mm Hg), severe liver impairment (AST or ALT > 3 x normal, cirrhosis), subject on dialysis
• Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or planned in the next 30 days after enrollment
• Indication for warfarin or heparin beyond enrollment (NOTE: exceptions allowed for subcutaneous heparin for deep vein thrombosis (DVT) prophylaxis while hospitalized)
• Diabetic subjects taking sulfonylurea drugs
• Severe neurological deficit that renders the subject incapable of living independently
• Dementia or psychiatric problem that prevents the subject from following the protocol reliably
• Co-morbid conditions that may limit survival to less than 3 months
• Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study
• Claustrophobia requiring sedation for MRI
• Enrollment in another study that would conflict with the current study