Limb Remote Ischemic Conditioning and Cerebrovascular Reserve

Ischemic Cerebrovascular Disease Clinical Trial

Official title:

Effects of Limb Remote Ischemic Conditioning (LRIC) on Cerebrovascular Reserve (CVR) in Ischemic Cerebrovascular Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03589053
• Other study ID #: LRIC-CVR
• Status: Recruiting
• Phase: Phase 2
• Start date: October 8, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: October 2018
• Source: Capital Medical University
• Contact: Xunming Ji, MD.PhD
• Phone: +86-10-83198952
• Email: jixunming[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Ischemia
• Ischemic Cerebrovascular Disease

Intervention

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.
• Control group
Participants in the control group receive both sham LRIC and standard clinical therapy.

Locations

Country	Name	City	State
China	Xunming Ji	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of LRIC [Number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC]	The safety of LRIC by the number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC.	90 days
Primary	Change of cerebrovascular reserve	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.	90 days
Secondary	Recurrence of stroke		90 days