Ischemic Cerebrovascular Disease
Conditions
Keywords
Limb remote ischemic conditioning, Cerebrovascular reserve
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.
Interventions
DEVICELimb 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.
DEVICEControl group
Participants in the control group receive both sham LRIC and standard clinical therapy.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of cerebrovascular reserve | 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
| Measure | Time frame |
|---|---|
| Recurrence of stroke | 90 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety of LRIC [Number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC] | 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. |
Countries
China
Contacts
Primary ContactXunming Ji, MD.PhD
Outcome results
None listed