Clinical Trial: Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Preconditioning and Cerebral Small Vessel Disease

Brief Summary: The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a beneficial effect on outcomes of cerebral small vessel disease (CSV).

Detailed Summary: CSV constitutes an important type of ischemic stroke due to a generalized hypo-perfusion of brain. Few treatment methods are available except some beneficial effect shown with nimodipine. The potential treatment effect of RIPC on protection of brain from cerebral small vessel disease has not been investigated. The investigators designed this randomized, double-blind, controlled clinical trial to examine (1) whether RIPC has a beneficial effect on brain lesions of CSV, and (2) whether RIPC can protect patients of CSV from cognitive deterioration. There are 2 arms in this trial: One arm is RIPC treatment, the other one is sham RIPC treatment. Brain lesions will be quantified by volumetric MRI, and Xe-CT will be used to evaluate cerebral blood perfusion. Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).
Sponsor: Capital Medical University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Capital Medical University

Dates:
Date Received: July 26, 2012
Date Started: July 2012
Date Completion:
Last Updated: November 25, 2014
Last Verified: November 2014