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

Acute Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04977869
• Other study ID #: SERIC-EVT
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD, PhD
• Phone: 0086-13756661217
• Email: doctor_yangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 498
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numeric rating scales (NRS) score during intervention	Numeric rating scales (NRS) score during intervention. Ranged from 0 to 10, a low value represents a less pain.	7 days
Other	The number of early withdrawal for safety or tolerability reasons	The number of early withdrawal for safety or tolerability reasons	7 days
Other	Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	24 hours, 7 days, 30±3 days, 90±3 days
Other	Heart rate at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	Heart rate at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	24 hours, 7 days, 30±3 days, 90±3 days
Primary	Proportion of patients with modified Rankin Scale (mRS) Score 0-2	Proportion of patients with modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.	3 months
Secondary	National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT. Ranged from 0 to 42, a low value represents a better outcome.	24 hours, 7 days, 30±3 days, 90±3 days
Secondary	Barthel Index (BI) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	Barthel Index (BI) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT. Ranged from 0 to 100, a high value represents a better outcome.	24 hours, 7 days, 30±3 days, 90±3 days
Secondary	modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT. Ranged from 0 to 6, a low value represents a better outcome.	24 hours, 7 days, 30±3 days, 90±3 days
Secondary	The expanded Thrombolysis In Cerebral Infarction (eTICI) scale immediately after EVT	eTICI grade 0 is equivalent to no reperfusion or 0% filling of the downstream territory; eTICI 1 reflects thrombus reduction without any reperfusion of distal arteries; eTICI 2a is reperfusion in less than half or 1-49% of the territory; eTICI 2b50 is 50-66% reperfusion, exceeding the modified TICI (mTICI) 2B threshold but below the original TICI 2B cut-off point; eTICI 2b67 is 67-89% reperfusion, exceeding TICI but below TICI 2C; eTICI 2c is equivalent to TICI 2C or 90-99% reperfusion; and eTICI 3 is complete or 100% reperfusion, tantamount to TICI 3.	immediately after EVT
Secondary	Vascular recanalization rate 24 hours after EVT	Vascular recanalization rate 24 hours after EVT	24 hours,
Secondary	Frequency of Hemorrhagic transformation during hospitalization	Frequency of Hemorrhagic transformation during hospitalization	7 days
Secondary	Frequency of adverse events during follow-up	Severe adverse events through day-90 after the onset of acute ischemic stroke.	90 days