Trial of Remote Ischemic Pre-conditioning in Vascular Cognitive Impairment (TRIC-VCI)
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ClinicalTrials.gov Identifier: NCT04109963 |
Recruitment Status :
Recruiting
First Posted : October 1, 2019
Last Update Posted : August 17, 2021
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Condition or disease | Intervention/treatment | Phase |
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Vascular Dementia Cerebral Small Vessel Diseases Cerebral Small Vessel Ischaemic Disease Vascular Cognitive Impairment | Device: Remote ischemic conditioning | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Prospective, randomized, parallel arm, open-label, blinded end-point (PROBE) design. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Outcomes will be assessed masked to treatment assignment. Participants will be aware of treatment assignment. |
Primary Purpose: | Treatment |
Official Title: | Trial of Remote Ischemic Pre-Conditioning in Vascular Cognitive Impairment |
Actual Study Start Date : | September 26, 2019 |
Estimated Primary Completion Date : | March 1, 2022 |
Estimated Study Completion Date : | March 1, 2022 |
Arm | Intervention/treatment |
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Active Comparator: RIC once per day
RIC performed once a day on one arm. Each RIC session will consist of 4 cycles of unilateral or simultaneous bilateral upper arm ischemia for 5 minutes followed by reperfusion for another 5 minutes. The procedure will be performed by using an electric auto-control device with cuffs that inflate to a pressure of 200 mmHg during the ischemic period.
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Device: Remote ischemic conditioning
Remote ischemic conditioning therapy to the upper arm will be delivered by an automated device (RIC VCI) manufactured by Seagull Aps (Denmark). |
Active Comparator: RIC twice per day
RIC performed twice a day on one arm, approximately 12 hours apart. Each RIC session will consist of 4 cycles of unilateral or simultaneous bilateral upper arm ischemia for 5 minutes followed by reperfusion for another 5 minutes. The procedure will be performed by using an electric auto-control device with cuffs that inflate to a pressure of 200 mmHg during the ischemic period.
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Device: Remote ischemic conditioning
Remote ischemic conditioning therapy to the upper arm will be delivered by an automated device (RIC VCI) manufactured by Seagull Aps (Denmark). |
- Adherence [ Time Frame: 30 days ]Proportion completing 80% or more sessions.
- Discontinuation [ Time Frame: 30 days ]Cessation of device use
- Randomization [ Time Frame: 14 days ]Proportion completing the run-in period and proceeding to randomization
- Physical examination [ Time Frame: 30 days ]Proportion with signs of arm soft tissue or neurovascular injury
- Arm deep venous thrombosis [ Time Frame: 30 days ]Arm deep venous thrombosis
- Pain [ Time Frame: 30 days ]Mean peak and end-cycle pain levels reported using the Numeric Rating Scale for pain (based on subjective report, ranging from 0 [no pain] to 10 [worst possible pain]).
- MRI cerebral blood flow [ Time Frame: 30 days and 90 days ]Change in cerebral blood flow measured by arterial spin label MRI
- MRI white matter hyperintensity volume [ Time Frame: 30 days and 90 days ]Change in white matter hyperintensity volume on FLAIR
- MRI diffusion tensor imaging [ Time Frame: 30 days and 90 days ]Change in MRI peak skeletonized mean diffusivity
- Global cognition [ Time Frame: 30 days and 90 days ]Change in Montreal Cognitive Assessment
- Neuropsychological tests [ Time Frame: 30 days and 90 days ]Change in Trail-Making A and B
- Neuropsychiatric symptoms [ Time Frame: 30 days and 90 days ]Change in Mild Behavioural Impairment Checklist

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Ages Eligible for Study: | 60 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109963
Contact: Eric E Smith, MD | 1-403-944-1594 | eesmith@ucalgary.ca | |
Contact: Karyn Fischer, RN | 1-403-210-7611 | Karyn.Fischer@albertahealthservices.ca |
Canada, Alberta | |
Foothills Medical Centre | Recruiting |
Calgary, Alberta, Canada, T2N 2T9 | |
Contact: Karyn Fischer, MD 403-210-7611 karyn.fischer@albertahealthservices.ca | |
Contact: Eric E Smith, RN 403-944-1594 eesmith@ucalgary.ca |
Principal Investigator: | Eric Smith, MD | University of Calgary |

The dataset with individual de-identified participant data will be hosted on the University of Calgary PRISM dataverse once the main results results are published. The identifier will be assigned when the dataset is uploaded.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT04109963 |
Other Study ID Numbers: |
REB19-0861 |
First Posted: | October 1, 2019 Key Record Dates |
Last Update Posted: | August 17, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The completely de-identified study dataset will be posted to the University of Calgary section of the PRISM dataverse at the time of publication of the main study results in a peer-reviewed journal. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | The study dataset will be made publicly available at the time of publication of the main study results in a peer-reviewed journal. |
Access Criteria: | Open to the public. |
URL: | https://dataverse.scholarsportal.info/dataverse/calgary |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
vascular cognitive impairment, cerebral small vessel diseases, remote ischemic conditioning |
Dementia, Vascular Cerebral Small Vessel Diseases Ischemia Cognitive Dysfunction Pathologic Processes Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders |
Mental Disorders Cognition Disorders Cerebrovascular Disorders Intracranial Arteriosclerosis Intracranial Arterial Diseases Leukoencephalopathies Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |