Remote Ischemic Conditioning on Cerebral Small Vessel Disease (RIC-SVD)
Primary Purpose
Cerebral Small Vessel Diseases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Automatic ischemic conditioning treatment instrument
Regular treatment
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Small Vessel Diseases focused on measuring Cerebral Small Vessel Diseases, Remote Ischemic Conditioning
Eligibility Criteria
Inclusion Criteria:
- 45-80 years old, and gender not limited;
- patient and/or caregiver report of cognitive declines with regard to memory and/or other cognitive domains lasting for at least 3 months;
- neither normal nor demented on the basis of the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) with normal or slightly impaired activities of daily living9, with Mini-mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above)10 and Montreal Cognitive Assessment (MoCA) score ≤ 26;
- the presence of lacunes and/or WMHs and/or CMBs on MRI
- absence of vascular narrowing >50% luminal diameter that could cause hemodynamic changes (MFV>90 cm/s for the intracranial internal carotid artery, 100 cm/s for MCA, >80 cm/s for basilar artery [BA] or vertebral artery) measured by TCD
Exclusion Criteria:
- clinical manifestations indicating that the patient was at the end-stage of cSVD;
- hereditary or inflammatory small vessel disorders
- cerebral venous injury or changes;
- diagnosis of nervous system degenerative diseases Alzheimer's disease, DLB, frontotemporal dementia (FTD), and so on;
- history of intracranial hemorrhage or significant bleeding in other parts of the body
- brain tumor, psychoses, or acute stroke within 6 months;
- cardiogenic embolism;
- significant bleeding coagulation dysfunction;
- serious liver and kidney function is not complete, malignant tumor, or serious diseases need to medical intervention or surgery;
- any soft tissue or vascular injury, and any disease of the extremities that may contraindicate RIC;
- pregnant women;
- life expectancy<6 months;
- refused to sign a consent form, poor compliance, or not to cooperate to complete whole treatment, and so on.
Sites / Locations
- Xuanwu hospital;Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
RIC group
Regular treatment
Arm Description
Device: Remote ischemic conditioning RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed twice daily for consecutive 1 year after enrollment.
Outcomes
Primary Outcome Measures
Changes of volume of WMHs
The volume of WMHs was measured on Flairs and DTI. By calculating the mean diffusivity (MD) and FA of water diffusion, DTI can assess the integrity and connectivity of WM tissue from a network perspective, and reconstruct the distribution of WM pathways in the brain three-dimensionally.
Secondary Outcome Measures
Changes in hemodynamic parameters on TCD.
The peak systolic, mean, and end diastolic blood flow velocities (BFV) at the most proximal segment of bilateral MCAs, BA were measured by TCD
Changes of cognition evaluation on MoCA.
The Beijing version of MoCA were used to evaluate to evaluate the cognitive functions of patients, referring to the degree of an individual's capacity with respect to orientation, memory, calculation, language, execution and visuospatial function and so on
Full Information
NCT ID
NCT04816500
First Posted
March 23, 2021
Last Updated
March 23, 2021
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04816500
Brief Title
Remote Ischemic Conditioning on Cerebral Small Vessel Disease
Acronym
RIC-SVD
Official Title
Study of Efficacy and Safety of Remote Ischemic Conditioning on Cerebral Small Vessel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is a randomized, controlled, single-center, double-blind trial. Cerebral small vessel disease (CSVD) patients will be recruited and randomized into RIC or control group.The protective effect of remote ischemic conditioning (RIC) on CSVD will be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Small Vessel Diseases
Keywords
Cerebral Small Vessel Diseases, Remote Ischemic Conditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RIC group
Arm Type
Experimental
Arm Description
Device: Remote ischemic conditioning RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed twice daily for consecutive 1 year after enrollment.
Arm Title
Regular treatment
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Automatic ischemic conditioning treatment instrument
Intervention Description
RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed twice daily for consecutive 1 year after enrollment.
Intervention Type
Drug
Intervention Name(s)
Regular treatment
Intervention Description
Antiplatelet agents and statins administration, vascular risk factors control.
Primary Outcome Measure Information:
Title
Changes of volume of WMHs
Description
The volume of WMHs was measured on Flairs and DTI. By calculating the mean diffusivity (MD) and FA of water diffusion, DTI can assess the integrity and connectivity of WM tissue from a network perspective, and reconstruct the distribution of WM pathways in the brain three-dimensionally.
Time Frame
From baseline to 1 year treatment
Secondary Outcome Measure Information:
Title
Changes in hemodynamic parameters on TCD.
Description
The peak systolic, mean, and end diastolic blood flow velocities (BFV) at the most proximal segment of bilateral MCAs, BA were measured by TCD
Time Frame
From baseline to 1 year treatment
Title
Changes of cognition evaluation on MoCA.
Description
The Beijing version of MoCA were used to evaluate to evaluate the cognitive functions of patients, referring to the degree of an individual's capacity with respect to orientation, memory, calculation, language, execution and visuospatial function and so on
Time Frame
From baseline to 1 year treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
45-80 years old, and gender not limited;
patient and/or caregiver report of cognitive declines with regard to memory and/or other cognitive domains lasting for at least 3 months;
neither normal nor demented on the basis of the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) with normal or slightly impaired activities of daily living9, with Mini-mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above)10 and Montreal Cognitive Assessment (MoCA) score ≤ 26;
the presence of lacunes and/or WMHs and/or CMBs on MRI
absence of vascular narrowing >50% luminal diameter that could cause hemodynamic changes (MFV>90 cm/s for the intracranial internal carotid artery, 100 cm/s for MCA, >80 cm/s for basilar artery [BA] or vertebral artery) measured by TCD
Exclusion Criteria:
clinical manifestations indicating that the patient was at the end-stage of cSVD;
hereditary or inflammatory small vessel disorders
cerebral venous injury or changes;
diagnosis of nervous system degenerative diseases Alzheimer's disease, DLB, frontotemporal dementia (FTD), and so on;
history of intracranial hemorrhage or significant bleeding in other parts of the body
brain tumor, psychoses, or acute stroke within 6 months;
cardiogenic embolism;
significant bleeding coagulation dysfunction;
serious liver and kidney function is not complete, malignant tumor, or serious diseases need to medical intervention or surgery;
any soft tissue or vascular injury, and any disease of the extremities that may contraindicate RIC;
pregnant women;
life expectancy<6 months;
refused to sign a consent form, poor compliance, or not to cooperate to complete whole treatment, and so on.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Wang, MD
Phone
+861083199085
Email
wilma0106@163.com
Facility Information:
Facility Name
Xuanwu hospital;Capital Medical University
City
Beijin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xunming Ji
Phone
+86-10-83198952
Email
jixunming@vip.163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Remote Ischemic Conditioning on Cerebral Small Vessel Disease
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