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

This study is currently recruiting participants.
Verified August 2012 by Capital Medical University
Sponsor:
Collaborator:
Peking University First Hospital
Information provided by (Responsible Party):
Ji Xunming, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01658306
First received: July 26, 2012
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Cerebral Small Vessel Disease
Procedure: remote ischemic preconditioning
Procedure: sham remote ischemic preconditioning
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Preconditioning and Cerebral Small Vessel Disease

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • changes in brain lesions [ Time Frame: 0-24 months ] [ Designated as safety issue: No ]
    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:
  • Changes in the cognitive function [ Time Frame: 0-24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Cerebral blood perfusion will be evaluated by Xe-CT.


Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: remote ischemic preconditioning
Receiving remote ischemic preconditioning (RIPC) treatment with pressure set at 200 mmHg.
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 Comparator: placebo remote ischemic preconditioning
Receiving sham RIPC treatment with pressure set at 50 mmHg
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.

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658306

Contacts
Contact: Xunming Ji, M.D., Ph.D. +86-13911077166 jixm70@hotmail.com
Contact: Yongxin Sun, M.D., Ph.D. +86-13910751948 sisisun@sina.com

Locations
China
Xuan Wu Hospital Recruiting
Beijing, China, 100053
Contact: Yongxin Sun, M.D., Ph.D.    +86-13910751948    sisisun@sina.com   
Contact: Yuan Wang, Ms.C.    +86-13581567815    wilma0106@163.com   
Principal Investigator: Xunming Ji, M.D., Ph.D.         
Sponsors and Collaborators
Capital Medical University
Peking University First Hospital
Investigators
Principal Investigator: Xunming Ji, M.D., Ph.D. Xuan Wu Hospital of Capital Medical University
  More Information

No publications provided

Responsible Party: Ji Xunming, Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University, Capital Medical University
ClinicalTrials.gov Identifier: NCT01658306     History of Changes
Other Study ID Numbers: D111107003111008
Study First Received: July 26, 2012
Last Updated: August 6, 2012
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by Capital Medical University:
remote ischemic preconditioning
random-controlled
double blind
RIPC

ClinicalTrials.gov processed this record on April 16, 2014