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The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency

NCT ID: NCT04069546

Last Updated: 2020-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-07

Study Completion Date

2020-02-01

Brief Summary

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to detect the effects of RIC on stroke-induced immunodeficiency and inflammation response in acute ischemic stroke patients

Detailed Description

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Remote ischemic conditioning, consisting of several brief cycles of intermittent ischemia-reperfusion of the arm or leg, may potentially confer systemic protection against prolonged ischemia in a distant organ. Numerous reports have confirmed its strongest endogenous neuroprotection against brain injury after stroke, of which the immune mechanisms are majorly involved in RIC. At the same time, the inflammation response plays a great role in stroke development, which may expand the infarct area. Stroke-induced immunodeficiency can potentiate stroke-associated pneumonia, which is an important cause of death after strokes. In this study, the investigators will assess the effect of RIC on stroke-induced immunodeficiency and inflammation response in AIS patients.

Conditions

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Acute Ischemic Stroke

Keywords

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Acute Ischemic Stroke Remote ischemic preconditioning Stroke-induced immunodeficiency Stroke-associated Pneumonia inflammation response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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AIS-RIC

RIC is a physical strategy performed through cuffs placed on the unilateral arm and inflated to 180 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times. This group of patients received regular therapy of acute ischemic stroke plus unilateral arm of RIC intervention.

Group Type EXPERIMENTAL

remote ischemic conditioning

Intervention Type DEVICE

RIC is a physical strategy performed by an electric device with cuffs placed on the unilateral arm and inflated to 180 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times.

AIS

This group of patients received regular therapy of acute ischemic stroke.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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remote ischemic conditioning

RIC is a physical strategy performed by an electric device with cuffs placed on the unilateral arm and inflated to 180 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age≥18 years old;
* Confirmed diagnosis of acute ischemic stroke(AIS) with onset of symptoms within 48h at recruitment;
* NIHSS score: ≤15;
* Prestroke modified Rankin Scale(mRS) ≤2;
* subject or his or her legally authorized representative was able to provide informed consent.

Exclusion Criteria

* uncontrolled hypertension (defined as systolic blood pressure ≥200 mmHg);
* participation in another device or drug trial simultaneously;
* any vascular, soft tissue, or orthopedic injury (eg, superficial wounds and fractures of the arm) that contraindicated unilateral arm ischemic preconditioning;
* peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion);
* Women who have a positive pregnancy test;
* History of malignancies;
* Using remote ischemic conditioning within the preceding 1 week;
* known infection at admission;
* a history of infection or the use of antibiotics, immunosuppressants, or steroids within the preceding 3 months.
* Other conditions are not suitable for this trial (evaluated by researchers)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ji Xunming,MD,PhD

Clinical Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, XI Cheng District,, China

Site Status

Countries

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China

Other Identifiers

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RIC-SIID

Identifier Type: -

Identifier Source: org_study_id