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Limb Remote Ischemic Conditioning and Cerebrovascular Reserve

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ClinicalTrials.gov Identifier: NCT03589053
Recruitment Status : Unknown
Verified October 2018 by Ji Xunming,MD,PhD, Capital Medical University.
Recruitment status was:  Recruiting
First Posted : July 17, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Xunming,MD,PhD, Capital Medical University

Study Description
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Brief Summary:
Cerebrovascular reserve (CVR), defined as the increase in cerebral blood flow (CBF)in response to a vasodilatory stimulus, is known to reflect the compensative capacity of the brain to maintain adequate blood flow in the face of decreased perfusion due to arterial stenosis. CVR dysfunction has been identified as an independent risk factor for ischemic stroke. Limb remote ischemic preconditioning （LRIC) has been suggested as a protective therapeutic modality against brain ischemia. So it is worth to detect whether LRIC can improve the CVR ability in ischemic cerebrovascular disease patients.

Condition or disease Intervention/treatment Phase
Ischemic Cerebrovascular Disease Device: Limb remote ischemic conditioning Device: Control group Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Limb Remote Ischemic Conditioning (LRIC) on Cerebrovascular Reserve (CVR) in Ischemic Cerebrovascular Disease Patients
Estimated Study Start Date : October 8, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : March 30, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: LRIC group
Participants in the experimental group receive both LRIC and standard clinical therapy. The LRIC treatment is composed of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 90 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion (Patent No.CN200820123637.X, China).
 Device: Limb remote ischemic conditioning
The LRIC treatment consisted of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 90 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion.
Sham Comparator: Control group
Participants in the control group receive both sham LRIC and standard clinical therapy.
 Device: Control group
Participants in the control group receive both sham LRIC and standard clinical therapy.


Outcome Measures
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Primary Outcome Measures :
  1. Change of cerebrovascular reserve [ Time Frame: 90 days ]
    We evaluate the compensatory capacity of cerebral blood vessels and brain tissue by the rate of changes in cerebral blood flow and brain metabolism under stress and resting conditions, respectively.


Secondary Outcome Measures :
  1. Recurrence of stroke [ Time Frame: 90 days ]

Other Outcome Measures:
  1. Safety of LRIC [Number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC] [ Time Frame: 90 days ]
    The safety of LRIC by the number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- (1)Symptomatic intracranial arterial stenosis measuring >=50% by angiography or >=70% by ultrasound, CT angiography (CTA), or magnetic resonance angiography (MRA);(2)Age range 18-80 years;(3)Compared with normal brain tissue, the reduction of cerebral glucose metabolism (CGM) and/ or cerebral blood flow (CBF) in the focal area>=8%;(4)Stable vital signs, normal renal and hepatic functions; (5)No hemorrhagic tendency;(6)Subject or his or her legally authorized representative was able to provide an informed conised.

Exclusion Criteria:

-(1)Uncontrolled hypertension (defined as systolic blood pressure>=200 mmHg despite medications at enrollment); (2)Any vascular, soft tissue, or orthopedic injury (eg, superficial wounds and fractures of the arm) that contraindicated bilateral arm ischemic preconditioning;(3)Peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion); (4)Hematologic disease;(5)Severe or unstable concomitant disease;(6)Can not tolerate LRIC treatment;(7)No informed consent.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589053


Contacts
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Contact: Xunming Ji, MD.PhD +86-10-83198952 jixunming@vip.163.com

Locations
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China, Beijing
Xunming Ji Recruiting
Beijing, Beijing, China, 100053
Contact: Hong An, MD       anhong0622@163.com   
Sponsors and Collaborators
Capital Medical University
Investigators
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Principal Investigator: Xunming Ji Capital Medical University
More Information
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Responsible Party: Ji Xunming,MD,PhD, professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT03589053    
Other Study ID Numbers: LRIC-CVR
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji Xunming,MD,PhD, Capital Medical University:
Limb remote ischemic conditioning
Cerebrovascular reserve
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Ischemia
Pathologic Processes
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases