Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease

Phase 3

Completed

• Conditions: Cerebral Small Vessel Disease
• Interventions: Procedure: sham remote ischemic preconditioning; Procedure: remote ischemic preconditioning

• Registration Number: NCT01658306
• Lead Sponsor: Capital Medical University

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 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).

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-07
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Subjects aged 40-80 years;
2. Ischemic cerebrovascular event onset, if any, must be within 6 months;
3. TCD and carotid ultrasound exclude vascular narrow that can cause hemodynamic changes (usually >50% narrow lumen);
4. MRI confirmed the presence of lacunar infarction and / or generalized white matter lesions;
5. Written consent was obtained from the subject.

Exclusion Criteria

1. History of intracranial hemorrhage;
2. Significant bleeding from other parts of the body;
3. History of atrial fibrillation;
4. History of myocardial infarction within six months;
5. Moyamoya disease or vasculitis;
6. Hereditary small vessel disorders, such as CADASIL, FABRY, and mitochondrial encephalo-myopathy;
7. Significant bleeding-coagulation dysfunction;
8. Abnormal blood pressure, glucose and/or lipids after restrict treatment regimen;
9. Severe liver/kidney disease, cancer or critical illness of internal medicine and surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo remote ischemic preconditioning	sham remote ischemic preconditioning	Receiving sham RIPC treatment with pressure set at 50 mmHg
remote ischemic preconditioning	remote ischemic preconditioning	Receiving remote ischemic preconditioning (RIPC) treatment with pressure set at 200 mmHg.

Primary Outcome Measures

Name	Time	Method
changes in brain lesions	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

Secondary Outcome Measures

Name	Time	Method
Changes in the cognitive function	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	0-24 months	Cerebral blood perfusion will be evaluated by Xe-CT.

Trial Locations

Locations (1)

Xuan Wu Hospital; 🇨🇳 Beijing, China