Chronic Remote Ischemic Conditioning in Vascular Cognitive Impairment: A Dose Escalation Study
NCT ID: NCT06179797
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2020-08-15
2023-12-15
Brief Summary
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Detailed Description
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Aim: We aim to measure blood biomarkers in response to daily remote ischemic conditioning (RIC) using a dose escalation study design in 40 patients with age-related cerebral white matter hyperintensities on MRI.
Hypothesis: We hypothesize that there will be a significant change in the biomarker levels in a dose dependent fashion.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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sham
BP cuff bilateral arm compression to 50 mmHg.
remote ischemic conditioning
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
dose 1
BP cuff bilateral arm compression to 50 mmHg above systolic BP for 2.5 minutes on/off for 4 cycles every other day.
remote ischemic conditioning
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
dose 2
BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off for 4 cycles every other day.
remote ischemic conditioning
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
dose 3
BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off once daily.
remote ischemic conditioning
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
dose 4
BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off twice daily.
remote ischemic conditioning
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
Interventions
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remote ischemic conditioning
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Head MRI in the past 6 months showing no more than moderate age related cerebral white matter changes (Fazekas score 0-2).
3. Able to walk without assistance \& independently perform basic activities of daily living.
4. Able to understand this study and agree for a valid consent.
Exclusion Criteria
4\. Contraindication to transient arm ischemia in either arm (such as symptomatic peripheral artery disease).
56 Years
ALL
No
Sponsors
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Georgia Rehabilitation Institute
UNKNOWN
Augusta University
OTHER
Responsible Party
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Askiel Bruno
MD
Principal Investigators
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Carol Smith, RN
Role: STUDY_DIRECTOR
Wellstar MCG Health
Locations
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Wellstar MCG Health
Augusta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Askiel Bruno, MD
Role: primary
Other Identifiers
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1513705-3
Identifier Type: -
Identifier Source: org_study_id