Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke

NCT ID: NCT04980651

Last Updated: 2024-10-02

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

RECRUITING

Clinical Phase

NA

Total Enrollment

2210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2025-10-01

Brief Summary

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The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.

Detailed Description

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In this study, 2210 cases of ischemic stroke in 72 hours were included in 10 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning in treating acute ischemic stroke.

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RIC+Standard medical treatment

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.

Group Type ACTIVE_COMPARATOR

Remote ischemic conditioning

Intervention Type PROCEDURE

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.

Sham RIC+Standard medical treatment

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.

Group Type PLACEBO_COMPARATOR

Sham remote ischemic conditioning

Intervention Type PROCEDURE

Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.

Interventions

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Remote ischemic conditioning

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.

Intervention Type PROCEDURE

Sham remote ischemic conditioning

Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1\) Age≥18 years, regardless of sex.
* 2\) Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 72 hours of stroke onset.
* 3\) Baseline NIHSS ≥ 4, ≤ 24.
* 4\) Baseline mRS ≤ 2;
* 5\) Signed and dated informed consent is obtained.

Exclusion Criteria

* 1\) Patients who undergo thrombolytic therapy or endovascular treatment.
* 2\) The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture, or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
* 3\) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumors,s and other diseases involving the brain.
* 4\) Pregnant or lactating women.
* 5\) Previous remote ischemic conditioning therapy or similar treatment.
* 6\) Severe hepatic and renal dysfunction.
* 7\) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
* 8\) Unwilling to be followed up or treated for poor compliance.
* 9\) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission.
* 10\) Other conditions that the researchers think are not suitable for the group.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yi Yang

OTHER

Sponsor Role lead

Responsible Party

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Yi Yang

Associated Dean of First Hospital of Jilin University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Yang, MD, PhD

Role: CONTACT

0086-13756661217

Zhenni Guo, MD, PhD

Role: CONTACT

Facility Contacts

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Yi Yang, MD,PHD

Role: primary

Other Identifiers

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SERIC

Identifier Type: -

Identifier Source: org_study_id

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