Effects of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients With Ischemic Stroke

NCT ID: NCT05915832

Last Updated: 2024-02-28

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

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-25

Study Completion Date

2025-03-01

Brief Summary

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The purpose of this study is to determine the impact of remote ischemic conditioning on cerebral hemodynamics in patients with ischemic stroke.

Detailed Description

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Current studies have shown that remote ischemic conditioning can activate neuronal signals and humoral factors, increase cerebral perfusion and promote neurological recovery in patients with ischemic stroke.The purpose of this study was to investigate the effect of remote ischemic conditioning on cerebral hemodynamics in patients with 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

DOUBLE

Participants Outcome Assessors

Study Groups

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RIC

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.

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

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.

Group Type PLACEBO_COMPARATOR

Sham 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 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

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, \<80 years, both sex;
2. Patients with a clinically definite diagnosis of acute ischemic stroke who are able to commence RIC treatment within 72 hours of stroke onset;
3. Baseline National Institute of Health Stroke Scale (NIHSS) score\<25;
4. Pre-onset modified Rankin Scale (mRS) score ≤ 1;
5. Glasgow Coma Scale score ≥8;
6. Signed and dated informed consent is obtained.

Exclusion Criteria

1. Patients who have undergone thrombolytic therapy or endovascular therapy;
2. Inability to cooperate sufficiently to complete the cerebral autoregulation examination (e.g., due to a condition such as agitation, drowsiness, arrhythmia, insufficient bilateral temporal bone windows, etc.) during the recording;
3. Presence of other intracranial lesions, such as cerebrovascular malformations, cerebral venous thrombosis, tumors, and other brain lesions;
4. severe hepatic and renal dysfunction or failure;
5. Patients with hematological disease, abnormal coagulation function, bleeding tendency, and platelet \<100×10\^9/L;
6. Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper extremities, venous thrombosis in the acute or subacute stage of upper extremities, arterial occlusive disease, subclavian artery stenosis ≥ 50%, or subclavian steal syndrome;
7. pregnant or lactating women;
8. Previous RIC treatment or similar treatment;
9. Patients with a life expectancy of less than 3 months or patients who are unable to complete the study for other reasons;
10. unwillingness to be followed up or poor treatment adherence;
11. Individuals who are participating in other clinical studies, have participated in other clinical studies within 3 months prior to enrollment, or have participated in this research;
12. Other conditions that the investigator considers inappropriate for enrollment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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

Vice President of The First Hospital of Jilin University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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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

13756661217 ext. 0086

Zhenni Guo, MD,PhD

Role: CONTACT

18186872986 ext. 0086

Facility Contacts

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Yi Yang, MD, PhD

Role: primary

18186870008 ext. 0086

Zhenni Guo, MD,PhD

Role: backup

18186872986 ext. 0086

Other Identifiers

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RICCH-IS

Identifier Type: -

Identifier Source: org_study_id

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