Remote Preconditioning Over Time To Empower Cerebral Tissue (REM-PROTECT)

This is an interventional prevention trial for Ischemic Stroke focused on measuring ischemic preconditioning, remote ischemic preconditioning, ischemic stroke, white matter disease, cerebral small vessel disease, cognitive decline, leukoaraiosis, diffusion tensor imaging, white matter hyper intensity score, European scale of age-related white matter change Read More

Inclusion Criteria:

I. Clinical

1. Clinical lacunar stroke syndrome within the past 6 months
2. Absence of signs or symptoms of cortical dysfunction
3. No proximal large vessel atherosclerosis, intracranial atherosclerosis or cerebellar stroke.
4. No major cardioembolic source requiring anticoagulation or other specific therapy

II. Imaging

1. Magnetic Resonance Imaging (MRI) presence of a small subcortical ischemic, any 1 or more of:

   1. Diffusion-weighted imaging (DWI) lesion < 2.0cm in size at largest dimension and corresponding to the clinical syndrome.
   2. Well delineated focal hyperintensity <2.0 cm in size at largest dimension (including rostro-caudal extent) on FLAIR or T2 and clearly corresponding to the clinical syndrome. If other focal hyperintensities are present, the case will be discussed with the principal investigator prior to randomization
   3. Multiple (at least 2) hypointense lesions of size 0.3-1.5 cm at largest dimension (including rostro-caudal extent) only in the cerebral hemispheres on FLAIR or T1 in patients whose qualifying event is clinically hemispheric
   4. Well delinated hypointense lesion <1.5 cm in size at the largest dimension (including rostro-caudal extent) on FLAIR or T1 corresponding to the clinical syndrome. MRI must be done at least 1 months after the qualifying stroke
2. Absence of cortical stroke and large (> 1.5cm) subcortical stroke, recent or remote
3. White matter hyperintensity score of 2 (moderate) or 3 (severe) on the European Scale of Age-Related White Matter Change
4. Absence of cerebral amyloid antipathy (CAA) as per Boston Criteria.

Exclusion Criteria:

1. Disabling stroke (Rankin Scale ≥4)
2. Previous intracranial hemorrhage (excluding traumatic) or hemorrhagic stroke
3. Age under 40 years
4. High risk of bleeding (e.g. recurrent GI or GU bleeding, active peptic ulcer disease, etc.)
5. Anticipated requirement for long term use of anticoagulants (e.g. recurrent deep venous thrombosis (DVT)
6. Prior cortical or retinal stroke (diagnosed either clinically or by neuroimaging), or other prior cortical or retinal transient ischemic attack (TIA)
7. Prior ipsilateral carotid endarterectomy
8. Impaired renal function: estimated GFR <40
9. Intolerance or contraindications to aspirin or clopidogrel (including thrombocytopenia, prolonged INR)
10. Mini Mental Status Exam score < 24 (adjusted for age and education)
11. Medical contraindication to MRI
12. Pregnancy or women of child-bearing age who are not following an effective method of contraception
13. Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
14. SBP <90 or > 200
15. Known history of limb vascular disease, limb vascular bypass surgery, or limb deep venous thrombosis
16. Prisoners
17. Homeless individuals
18. Patient unable to give informed consent and no available legally authorized representative to provide informed consent
19. Patient unlikely to be compliant with therapy/ unwilling to return for follow up visits
20. Concurrent participation in another study with investigational drug or device treatment
21. Other likely specific cause of stroke (e.g. dissection, vasculitis, prothrombotic diathesis, drug abuse)