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Limb Remote Ischemic Conditioning and Cerebrovascular Reserve

Primary Purpose

Ischemic Cerebrovascular Disease

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Limb remote ischemic conditioning

Control group

About this trial

This is an interventional treatment trial for Ischemic Cerebrovascular Disease focused on measuring Limb remote ischemic conditioning, Cerebrovascular reserve

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Xunming JiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

LRIC group

Control group

Arm 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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Recurrence of stroke

Full Information

NCT ID

NCT03589053

First Posted

June 28, 2018

Last Updated

October 5, 2018

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03589053

Brief Title

Limb Remote Ischemic Conditioning and Cerebrovascular Reserve

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 8, 2018 (Anticipated)

Primary Completion Date

December 30, 2018 (Anticipated)

Study Completion Date

March 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Cerebrovascular Disease

Keywords

Limb remote ischemic conditioning, Cerebrovascular reserve

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LRIC group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Limb remote ischemic conditioning

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Control group

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of cerebrovascular reserve

Description

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.

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Recurrence of stroke

Time Frame

90 days

Other Pre-specified Outcome Measures:

Title

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

Description

The safety of LRIC by the number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC.

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xunming Ji, MD.PhD

Phone

+86-10-83198952

jixunming@vip.163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xunming Ji

Organizational Affiliation

Capital Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xunming Ji

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hong An, MD

anhong0622@163.com

12. IPD Sharing Statement

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