Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease (RIPC-SVD)

Capital Medical University

Status and phase: Completed; Phase 3

Conditions: Cerebral Small Vessel Disease

Treatments: Procedure: sham remote ischemic preconditioning; Procedure: remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01658306

D111107003111008

Details and patient eligibility

About

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

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

remote ischemic preconditioning

Experimental group

Description:

Receiving remote ischemic preconditioning (RIPC) treatment with pressure set at 200 mmHg.

Treatment:

Procedure: remote ischemic preconditioning

placebo remote ischemic preconditioning

Sham Comparator group

Description:

Receiving sham RIPC treatment with pressure set at 50 mmHg

Treatment:

Procedure: sham remote ischemic preconditioning