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Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation

Recruiting
18 years of age
Both
Phase N/A

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Overview

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.

Description

In this study, 498 cases of ischemic stroke who undergo endovascular thrombectomy within 24 hours from the onset are 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 for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.

Eligibility

Inclusion Criteria:

  • 1) Age ≥ 18 years, male or female
  • 2) Diagnosis of acute ischemic stroke due to large vessel occlusion of anterior circulation (large artery occlusion confirmed by head CTA or DSA) and history of emergent endovascular thrombectomy
  • 3) Baseline NIHSS ≥ 6
  • 4) Premorbid mRS ≤ 2
  • 5) Written informed consent obtained from the patient or legally responsible person

Exclusion Criteria:

  • 1) Contraindication of endovascular thrombectomy
  • 2) Contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, and subclavian steal syndrome
  • 3) Head CT showing cerebral hernia and midline displacement
  • 4) Pregnancy or lactation
  • 5) Previous remote ischemic conditioning therapy or similar treatment
  • 6) Severe hepatic and renal dysfunction
  • 7) Life expectancy of less than 3 months or inability to complete the study for other reasons
  • 8) Unwilling to be followed up or poor compliance
  • 9) Current or past participation in other clinical research, or participation in this study within 3 months prior to admission
  • 10) Other conditions that the researchers think make the patient unsuitable for the study

Study details

Acute Ischemic Stroke

NCT04977869

Yi Yang

8 March 2024

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