Recruiting
Phase 2

Remote Ischemic Pre-conditioning

Sponsor:

University of Calgary

Code:

NCT04109963

Conditions

Vascular Dementia

Cerebral Small Vessel Diseases

Cerebral Small Vessel Ischaemic Disease

Vascular Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Remote ischemic conditioning

Study Details

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 to increase tolerance of the brain to hypoperfusion and increase cerebral blood flow. Patients with cognitive impairment, preserved basic activities of daily living, and brain computed tomography (CT) or magnetic resonance imaging (MRI) evidence of confluent white matter hyperintensities or multiple brain infarcts will be randomized to either RIC performed once a day on one arm, or twice per day on one arm, for 30 days, to test tolerability and effects on MRI markers of blood flow.

Conditions

Vascular Dementia

Cerebral Small Vessel Diseases

Cerebral Small Vessel Ischaemic Disease

Vascular Cognitive Impairment

Study ID

NCT04109963

Start date

Sep 26, 2019

Status verified date

Aug, 2021

Completion date

Mar 1, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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).

Primary outcome measure

  • Adherence [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Eric E Smith, MD

1-403-944-1594eesmith@ucalgary.ca

Karyn Fischer, RN

1-403-210-7611Karyn.Fischer@albertahealthservices.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Karyn Fischer, MD

403-210-7611karyn.fischer@albertahealthservices.ca

Eric E Smith, RN

403-944-1594eesmith@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Jun 9, 2022

Last verified

Aug, 2021

Keywords

  • vascular cognitive impairment, cerebral small vessel diseases, remote ischemic conditioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-06-09.