Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke

  • STATUS
    Recruiting
  • End date
    Oct 1, 2024
  • participants needed
    2210
  • sponsor
    Yi Yang
Updated on 20 September 2021

Summary

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

Description

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.

Details
Condition Acute Ischemic Stroke
Treatment Remote Ischemic conditioning, Sham Remote Ischemic Conditioning
Clinical Study IdentifierNCT04980651
SponsorYi Yang
Last Modified on20 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

) Age18 years, regardless of sex
) Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 72 hours of stroke onset
) Baseline NIHSS 4, 24
) Baseline mRS 2
) Signed and dated informed consent is obtained

Exclusion Criteria

) Patients who undergo thrombolytic therapy or endovascular treatment
) 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
) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumors,s and other diseases involving the brain
) Pregnant or lactating women
) Previous remote ischemic conditioning therapy or similar treatment
) Severe hepatic and renal dysfunction
) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons
) Unwilling to be followed up or treated for poor compliance
) 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
) Other conditions that the researchers think are not suitable for the group
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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