Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease
Information source: Capital Medical University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Small Vessel Disease
Intervention: remote ischemic preconditioning (Procedure); sham remote ischemic preconditioning (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: Capital Medical University Official(s) and/or principal investigator(s): Xunming Ji, M.D., Ph.D., Principal Investigator, Affiliation: Xuan Wu Hospital of Capital Medical University
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).
Clinical Details
Official title: A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Preconditioning and Cerebral Small Vessel Disease
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: changes in brain lesions
Secondary outcome: Changes in the cognitive functionChanges in the cerebral blood perfusion
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).
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Xuan Wu Hospital, Beijing 100053, China
Additional Information
Starting date: July 2012
Last updated: November 25, 2014
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