Remote Preconditioning Over Time To Empower Cerebral Tissue

Stopped early · Not applicable

Conditions studied: Ischemic Stroke, Cerebral Small Vessel Disease, Cognitive Decline

In brief

Previous studies in animals and humans has shown that brief periods of reduced blood flow to one organ or tissue in the body can help protect other tissues from subsequent injury caused by reduced blood flow such as a stroke. This phenomenon is known as remote ischemic preconditioning and may help protect brain cells after a stroke. The investigators are studying a specific stroke type called subcortical stroke that is very common and has a high rate of recurrent stroke and cognition problems despite intensive prevention measures.

Key facts

Study ID

NCT02169739

Run by

University of California, Los Angeles

People needed

6

Starts

2015-11-01

Expected to finish

2020-03-01

Last updated by the study team

2021-03-10

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• I. Clinical
• Clinical lacunar stroke syndrome within the past 6 months
• Absence of signs or symptoms of cortical dysfunction
• No proximal large vessel atherosclerosis, intracranial atherosclerosis or cerebellar stroke.
• No major cardioembolic source requiring anticoagulation or other specific therapy
• II. Imaging
• Magnetic Resonance Imaging (MRI) presence of a small subcortical ischemic, any 1 or more of:
• Diffusion-weighted imaging (DWI) lesion < 2.0cm in size at largest dimension and corresponding to the clinical syndrome.
• 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
• 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
• 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
• Absence of cortical stroke and large (> 1.5cm) subcortical stroke, recent or remote
• White matter hyperintensity score of 2 (moderate) or 3 (severe) on the European Scale of Age-Related White Matter Change
• Absence of cerebral amyloid antipathy (CAA) as per Boston Criteria.

You may not qualify if…

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

Where it is running

• University of California Los Angeles UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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