Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02169739 : Remote Preconditioning Over Time To Empower Cerebral Tissue
PhaseN/A
AgesMin: 40 Years Max: N/A
Eligibility
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)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02169739      |      Link to official Clinicaltrials.gov listing
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