Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease (RIPC-SVD)
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|ClinicalTrials.gov Identifier: NCT01658306|
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : November 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Small Vessel Disease||Procedure: remote ischemic preconditioning Procedure: sham remote ischemic preconditioning||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Preconditioning and Cerebral Small Vessel Disease|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: remote ischemic preconditioning
Receiving remote ischemic preconditioning (RIPC) treatment with pressure set at 200 mmHg.
Procedure: remote ischemic preconditioning
RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the RIPC group will have the treatment twice a day for two weeks.
Sham Comparator: placebo remote ischemic preconditioning
Receiving sham RIPC treatment with pressure set at 50 mmHg
Procedure: sham remote ischemic preconditioning
Sham RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 50 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the placebo RIPC group will have the treatment twice a day for two weeks.
- changes in brain lesions [ Time Frame: 0-24 months ]Volumetric MRI will be used for calculating changes in the number of lacunar infarctions and the total volume of white matter lesions
- Changes in the cognitive function [ Time Frame: 0-24 months ]Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).
- Changes in the cerebral blood perfusion [ Time Frame: 0-24 months ]Cerebral blood perfusion will be evaluated by Xe-CT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658306
|Xuan Wu Hospital|
|Beijing, China, 100053|
|Principal Investigator:||Xunming Ji, M.D., Ph.D.||Xuan Wu Hospital of Capital Medical University|