Status:
UNKNOWN
Trial of Remote Ischemic Pre-conditioning in Vascular Cognitive Impairment
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Canadian Consortium on Neurodegeneration in Aging
Conditions:
Vascular Dementia
Cerebral Small Vessel Diseases
Eligibility:
All Genders
60-85 years
Phase:
PHASE2
Brief Summary
Cerebral small vessel disease is a common cause of cognitive impairment. Remote ischemic pre-conditioning (RIC) is a technique to induce brief periods of limb ischemia-reperfusion that is hypothesized...
Detailed Description
Cerebral small vessel disease (cSVD) accounts for 20-25% of all strokes and is the most common cause of vascular cognitive impairment (VCI) as well as a major contributor to mixed dementia, potentiall...
Eligibility Criteria
Inclusion
- Evidence of cerebral small vessel disease on CT or MRI, defined as either beginning confluent white matter hypodensities/hyperintensities (ARWMC scale) or two or more supratentorial infarcts
- Montreal Cognitive Assessment \<25
- Concern on the part of the patient, caregiver, or clinician that there has been a decline from previous level of cognitive functioning
- Independent with basic activities of daily living (response (a) to questions 2, 4, 5, 6, 7, 8, 9, and 14 on the Bristol Activities of Daily Living scale).
Exclusion
- Cortical infarcts larger than 10 mm axial diameter
- Neuroimaging evidence of mass lesion, intracerebral hemorrhage, vascular malformation, or evidence of non-vascular disease such as hydrocephalus.
- Residence in long-term care facility.
- Other significant neurological or psychiatric disease (e.g. multiple sclerosis).
- Does not have a study partner who can provide corroborative information.
- English or French is not sufficiently proficient for clinical assessment and neuropsychological testing
- Montreal Cognitive Assessment score \<13
- Unable to undergo MRI due to medical contraindications or inability to tolerate the procedure.
- Co-morbid medical illness that in the judgment of the study investigator makes it unlikely that the participant will be able to complete three months of study follow-up.
- On therapeutic anticoagulation with doses used for treatment of deep venous thrombosis, pulmonary embolism, or for stroke prevention in atrial fibrillation.
- Significant bleeding diathesis.
- Any symptomatic or previously known arm soft-tissue disease, vascular injury, or peripheral vascular disease
- Hypertension with systolic blood pressure \>=180 mmHg despite medical treatment at the time of enrolment.
- Planned revascularization (any angioplasty or vascular surgery) within the next 3 months.
- Planned surgical procedure within the next 3 months.
- Currently receiving an investigational drug or device by other studies
- Blood pressure cuff cannot be sized properly (arm circumference is \<23 cm or \>42 cm)
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04109963
Start Date
September 26 2019
End Date
March 1 2023
Last Update
June 9 2022
Active Locations (1)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9