Limb Remote Ischemic Conditioning and Cerebrovascular Reserve

NCT03589053 | Unknown Phase 2 DMC

• 1 other identifier: LRIC-CVR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Cerebrovascular Disease

Keywords

Limb remote ischemic conditioning; Cerebrovascular reserve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Recurrence of stroke

  90 days

Other Outcomes (1)

• Safety of LRIC [Number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC]

  90 days

Study Arms (2)

LRIC group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Device: Control group

Interventions

Limb remote ischemic conditioning DEVICE

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.

LRIC group

Control group DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xunming Ji

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xunming Ji

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji, MD.PhD

CONTACT

+86-10-83198952; jixunming@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 17, 2018
• Study Start: October 8, 2018
• Primary Completion: December 30, 2018
• Study Completion: March 30, 2019
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

CN (1)