Clinical trial NCT04977869: Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation
Official title: Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation: A Multicenter, Randomized, Parallel-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 criteria: Inclusion Criteria:

* 1) Age ≥ 18 years, male or female
* 2) Diagnosis of acute ischemic stroke within 24 hours of symptom onset and underwent endovascular thrombectomy (EVT) adhering to current guidelines for large vessel occlusion in the anterior circulation (confirmed by computed tomography angiography or digital subtraction angiography)
* 3) Pre-EVT 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

Primary outcomes:
measure: Proportion of patients with modified Rankin Scale (mRS) Score 0-2
timeFrame: 3 months
Secondary outcomes:
measure: National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT.
timeFrame: 24 hours, 7 days (or discharge)
measure: Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT.
timeFrame: 24 hours, 7 days (or discharge)
measure: Proportion of patients with modified Rankin Scale (mRS) 0-1
timeFrame: 90±3 days
measure: modified Rankin Scale (mRS) score distribution
timeFrame: 90±3 days
measure: Recanalization rate within 7 days after EVT
timeFrame: 7 days
measure: Early neurological deterioration at 7 days
timeFrame: 7 days
measure: Frequency of Hemorrhagic transformation within 7 days
timeFrame: 7 days
measure: Frequency of symptomatic intracranial hemorrhage within 7 days
timeFrame: 7 days
measure: Death within 90 days
timeFrame: 90±3 days
measure: Frequency of adverse events within 90 days
timeFrame: 90±3 days
measure: Adverse events associated with remote ischemic conditioning within 90 days
timeFrame: 90±3 days
measure: Frequency of serious adverse events within 90 days
timeFrame: 90±3 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: