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Limb Remote Ischemic Conditioning and Cerebrovascular Reserve

C

Capital Medical University

Status and phase

Unknown
Phase 2

Conditions

Ischemic Cerebrovascular Disease

Treatments

Device: Control group
Device: Limb remote ischemic conditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT03589053
LRIC-CVR

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups

LRIC group
Experimental group
Description:
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).
Treatment:
Device: Limb remote ischemic conditioning
Control group
Sham Comparator group
Description:
Participants in the control group receive both sham LRIC and standard clinical therapy.
Treatment:
Device: Control group

Trial contacts and locations

1

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Central trial contact

Xunming Ji, MD.PhD

Data sourced from clinicaltrials.gov

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