NCT01658306

Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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).

Conditions

• Cerebral Small Vessel Disease

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-08-07
• Last updated: 2014-11-26

Locations

1 site across 1 country: China