Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease

Cerebral Small Vessel Disease Clinical Trial

— RIPC-SVD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658306
• Other study ID #: D111107003111008
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2012
• Last updated: November 25, 2014
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Small Vessel Disease
• Cerebral Small Vessel Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Xuan Wu Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Capital Medical University	Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in brain lesions	Volumetric MRI will be used for calculating changes in the number of lacunar infarctions and the total volume of white matter lesions	0-24 months	No
Secondary	Changes in the cognitive function	Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).	0-24 months	No
Secondary	Changes in the cerebral blood perfusion	Cerebral blood perfusion will be evaluated by Xe-CT.	0-24 months	No