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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658306
First Posted: August 7, 2012
Last Update Posted: November 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Peking University First Hospital
Information provided by (Responsible Party):
Ji Xunming, Capital Medical University
July 26, 2012
August 7, 2012
November 26, 2014
July 2012
June 2014   (Final data collection date for primary outcome measure)
changes in brain lesions [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT01658306 on ClinicalTrials.gov Archive Site
  • Changes in the cognitive function [ Time Frame: 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 [ Time Frame: 0-24 months ]
    Cerebral blood perfusion will be evaluated by Xe-CT.
Same as current
Not Provided
Not Provided
 
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
The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a beneficial effect on outcomes of cerebral small vessel disease (CSV).
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).
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cerebral Small Vessel Disease
  • 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.
  • Experimental: remote ischemic preconditioning
    Receiving remote ischemic preconditioning (RIPC) treatment with pressure set at 200 mmHg.
    Intervention: Procedure: remote ischemic preconditioning
  • Sham Comparator: placebo remote ischemic preconditioning
    Receiving sham RIPC treatment with pressure set at 50 mmHg
    Intervention: Procedure: sham remote ischemic preconditioning
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01658306
D111107003111008
Yes
Not Provided
Not Provided
Ji Xunming, Capital Medical University
Capital Medical University
Peking University First Hospital
Principal Investigator: Xunming Ji, M.D., Ph.D. Xuan Wu Hospital of Capital Medical University
Capital Medical University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP