Remote Ischemic Conditioning on Cerebral Small Vessel Disease

NCT ID: NCT04816500

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-12-31

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.

Conditions

Cerebral Small Vessel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RIC group

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.

Group Type: EXPERIMENTAL

Automatic ischemic conditioning treatment instrument

Intervention Type: DEVICE

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.

Regular treatment

Group Type: OTHER

Regular treatment

Intervention Type: DRUG

Antiplatelet agents and statins administration, vascular risk factors control.

Interventions

Automatic ischemic conditioning treatment instrument

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: DEVICE

Regular treatment

Antiplatelet agents and statins administration, vascular risk factors control.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 45-80 years old, and gender not limited;

2. patient and/or caregiver report of cognitive declines with regard to memory and/or other cognitive domains lasting for at least 3 months;

3. 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;

4. the presence of lacunes and/or WMHs and/or CMBs on MRI

5. 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

1. clinical manifestations indicating that the patient was at the end-stage of cSVD;

2. hereditary or inflammatory small vessel disorders

3. cerebral venous injury or changes;

4. diagnosis of nervous system degenerative diseases Alzheimer's disease, DLB, frontotemporal dementia (FTD), and so on;

5. history of intracranial hemorrhage or significant bleeding in other parts of the body

6. brain tumor, psychoses, or acute stroke within 6 months;

7. cardiogenic embolism;

8. significant bleeding coagulation dysfunction;

9. serious liver and kidney function is not complete, malignant tumor, or serious diseases need to medical intervention or surgery;

10. any soft tissue or vascular injury, and any disease of the extremities that may contraindicate RIC;

11. pregnant women;

12. life expectancy<6 months;

13. refused to sign a consent form, poor compliance, or not to cooperate to complete whole treatment, and so on.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Study of Efficacy and Safety of remote ischemic conditioning on cerebral small vessel disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xuanwu hospital;Capital Medical University

Beijin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuan Wang, MD

Role: CONTACT

wilma0106@163.com

+861083199085

Facility Contacts

Xunming Ji

Role: primary

jixunming@vip.163.com

+86-10-83198952

Other Identifiers

Capital Medical U

Identifier Type: -

Identifier Source: org_study_id