International Stroke Conference 2025  /  Brain Health Posters II  /  A Phase 2a randomized controlled trial of once-daily versus twice-daily remote ischemic conditioning in vascular cognitive impairment (TRIC-VCI)
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American Heart Association

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Final ID: TP39

A Phase 2a randomized controlled trial of once-daily versus twice-daily remote ischemic conditioning in vascular cognitive impairment (TRIC-VCI)

Abstract Body: Background: Cerebral small vessel disease (CSVD) is a leading cause of vascular cognitive impairment (VCI). Remote ischemic conditioning (RIC) is a promising strategy to prevent CSVD progression, but it is unclear what doses of daily RIC are tolerable or adherable for older patients with CSVD-associated VCI.

Methods: TRIC-VCI (ClinicalTrials.gov NCT04109963) was a prospective, open-label randomized-controlled trial with blinded endpoint assessment. Participants completing a 14-day run-in were randomized to once- or twice-daily RIC for 30 consecutive days. RIC consisted of 4 cycles of blood-pressure cuff inflation to 200mmHg around an arm for 5-minutes followed by 5-minutes deflation using an automated device. Criteria included age 60-85, evidence of CSVD on CT/MRI, Montreal Cognitive Assessment score 13-24, and preserved basic activities of daily living. Outcomes were assessed at 30- and 90-days. The primary outcome for which the trial was powered was adherence (completing ≥80% of sessions). Secondary outcomes included percentage of sessions completed and pain/discomfort scores from patient diaries. Exploratory outcomes included changes in white-matter hyperintensity (WMH) volume and cognitive tests. We explored trial experiences in a focus group with 5 patients and 4 care-partners.

Results: Among 23 patients entering the run-in, 22 completed it and were randomized. 21/22(95.5%) finished the 30-day treatment period. 7/11(63.6%) in the once-daily RIC group completed ≥80% of sessions vs 10/11(90.9%) in the twice-daily group; median session completion was 93%(IQR:73-98%) vs 98%(IQR:93-98%) respectively. Pain/discomfort ratings were numerically higher in the twice-daily group (median rating/10: 4.2, IQR 1.0-5.0 vs once-daily:1.6, IQR 1.0-3.4, p=0.60). None of the patients developed tissue/neurovascular injury or deep vein thrombosis. Cognitive tests generally did not change significantly or differ between groups; WMH volumes were stable (change at 90-days vs randomization: -0.21 mL, 95%CI -0.54-0.13). Focus group participants opined the device was easy to use, desired greater portability, generally favoured once-daily RIC, and were open to longer treatment courses in future trials.

Conclusion: RIC was safe and tolerated by patients with CSVD-associated VCI. Patients adhered well to both once- and twice-daily RIC, with no significant differences in outcomes between both groups. We will incorporate participant feedback into device design and future efficacy trials.
  • Ganesh, Aravind  ( UNIVERSITY OF CALGARY , Calgary , Alberta , Canada )
  • Mccreary, Cheryl  ( UNIVERSITY OF CALGARY , Calgary , Alberta , Canada )
  • Sahlas, Demetrios  ( McMaster University PHRI , Hamilton , Ontario , Canada )
  • Sharma, Mukul  ( McMaster University PHRI , Hamilton , Ontario , Canada )
  • Swartz, Richard  ( SUNNYBROOK HSC , Toronto , Ontario , Canada )
  • Smith, Eric  ( UNIVERSITY OF CALGARY , Calgary , Alberta , Canada )
  • Barber, Philip  ( UNIVERSITY OF CALGARY , Calgary , Alberta , Canada )
  • Black, Sandra  ( SUNNYBROOK HEALTH SCIENCE CTR MED , Toronto , Ontario , Canada )
  • Corbett, Dale  ( UNIVERSITY OF OTTAWA , Ottawa , Ontario , Canada )
  • Field, Thalia  ( UNIVERSITY OF BRITISH COLUMBIA , Vancouver , British Columbia , Canada )
  • Frayne, Richard  ( UNIVERSITY OF CALGARY , Calgary , Alberta , Canada )
  • Hachinski, Vladimir  ( University of Western Ontario , London , Ontario , Canada )
  • Ismail, Zahinoor  ( UNIVERSITY OF CALGARY , Calgary , Alberta , Canada )
  • Mai, Lauren  ( University of Western Ontario , London , Ontario , Canada )
    • Author Disclosures:
    Aravind Ganesh: DO have relevant financial relationships ; Ownership Interest:SnapDx Inc:Active (exists now) ; Research Funding (PI or named investigator):Philips Foundation:Past (completed) ; Research Funding (PI or named investigator):Microvention:Past (completed) ; Speaker:Biogen:Past (completed) ; Speaker:Alexion:Past (completed) ; Consultant:Servier Canada:Past (completed) ; Ownership Interest:Let's Get Proof (Collavidence Inc):Active (exists now) | Cheryl McCreary: DO NOT have relevant financial relationships | Demetrios Sahlas: No Answer | Mukul Sharma: DO have relevant financial relationships ; Research Funding (PI or named investigator):Bayer:Active (exists now) ; Research Funding (PI or named investigator):Daiichi Sakyo:Active (exists now) ; Research Funding (PI or named investigator):Portola:Past (completed) ; Research Funding (PI or named investigator):Alexion:Past (completed) ; Consultant:Bayer:Active (exists now) ; Research Funding (PI or named investigator):Astra Zeneca:Active (exists now) ; Research Funding (PI or named investigator):Janssen:Past (completed) ; Research Funding (PI or named investigator):BMS:Past (completed) | Richard Swartz: No Answer | Eric Smith: DO NOT have relevant financial relationships | Philip Barber: DO NOT have relevant financial relationships | Sandra Black: DO have relevant financial relationships ; Research Funding (PI or named investigator):Genentech, ICON:Past (completed) ; Consultant:Cpdnetwork planning committee for AD educational Program:Past (completed) ; Consultant:Eisai:Active (exists now) ; Consultant:Roche:Active (exists now) ; Consultant:Biogen:Past (completed) ; Advisor:Ontario Dementia Care Alliance (ODCA):Active (exists now) ; Advisor:National Institute of Neurological Disorders and Stroke:Active (exists now) ; Advisor:World Dementia Council University of Rochester Contribution to the Mission and Scientific Leadership of the Small Vessel VCID Biomarker Validation Consortium :Past (completed) ; Consultant:DSR: Diagnosis, Solutions & Results Inc:Past (completed) ; Advisor:Conference Board of Canada :Past (completed) ; Research Funding (PI or named investigator):Ontario Brain Institute, CIHR, Leducq Foundation, Heart and Stroke Foundation of Canada, NIH, Alzheimer's Drug Discovery Foundation, Brain Canada, Weston Brain Institute, Canadian Partnership for Stroke Recovery, Canadian Foundation for Innovation, Focused Ultrasound Foundation, Alzheimer's Association US, Queen’s University, Compute Canada Resources for Research Groups, CANARIE, Networks of Centres of Excellence of Canada:Active (exists now) ; Consultant:Eli Lilly:Active (exists now) ; Consultant:NovoNordisk:Active (exists now) ; Research Funding (PI or named investigator):Aribio:Expected (by end of conference) ; Research Funding (PI or named investigator):Optina, Lilly Avid:Active (exists now) | Dale Corbett: No Answer | Thalia Field: DO have relevant financial relationships ; Research Funding (PI or named investigator):Bayer:Past (completed) ; Advisor:Roche:Past (completed) ; Advisor:Novartis:Past (completed) ; Advisor:HLS Therapeutics:Past (completed) ; Advisor:Bayer:Active (exists now) | Richard Frayne: DO NOT have relevant financial relationships | Vladimir Hachinski: DO NOT have relevant financial relationships | Zahinoor Ismail: No Answer | Lauren Mai: DO NOT have relevant financial relationships
Meeting Info:

International Stroke Conference 2025

2025

Los Angeles, CA

Session Info:

Brain Health Posters II

Thursday, 02/06/2025 , 07:00PM - 07:30PM

Poster Abstract Session

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