Trial of Remote Ischemic Pre-conditioning in Vascular Cognitive Impairment
TRIC-VCI
Trial of Remote Ischemic Pre-Conditioning in Vascular Cognitive Impairment
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2019
CompletedFirst Submitted
Initial submission to the registry
September 27, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedJune 9, 2022
August 1, 2021
3.3 years
September 27, 2019
June 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence
Proportion completing 80% or more sessions.
30 days
Secondary Outcomes (11)
Discontinuation
30 days
Randomization
14 days
Physical examination
30 days
Arm deep venous thrombosis
30 days
Pain
30 days
- +6 more secondary outcomes
Study Arms (2)
RIC once per day
ACTIVE COMPARATORRIC 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.
RIC twice per day
ACTIVE COMPARATORRIC 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 therapy to the upper arm will be delivered by an automated device (RIC VCI) manufactured by Seagull Aps (Denmark).
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
Related Publications (1)
Ganesh A, Barber P, Black SE, Corbett D, Field TS, Frayne R, Hachinski V, Ismail Z, Mai LM, McCreary CR, Sahlas D, Sharma M, Swartz RH, Smith EE. Trial of remote ischaemic preconditioning in vascular cognitive impairment (TRIC-VCI): protocol. BMJ Open. 2020 Oct 14;10(10):e040466. doi: 10.1136/bmjopen-2020-040466.
PMID: 33055122DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Smith, MD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes will be assessed masked to treatment assignment. Participants will be aware of treatment assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2019
First Posted
October 1, 2019
Study Start
September 26, 2019
Primary Completion
December 31, 2022
Study Completion
March 1, 2023
Last Updated
June 9, 2022
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.