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

NCT04977869 | Completed DMC

• 1 other identifier: SERIC-EVT
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT.

  24 hours, 7 days (or discharge)

• Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT.

  24 hours, 7 days (or discharge)

• Proportion of patients with modified Rankin Scale (mRS) 0-1

  90±3 days

• modified Rankin Scale (mRS) score distribution

  90±3 days

• Recanalization rate within 7 days after EVT

  7 days

Study Arms (2)

RIC+Standard medical treatment

ACTIVE COMPARATOR

RIC+Standard medical treatment 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 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.

Procedure: Remote ischemic conditioning

Sham RIC+Standard medical treatment

PLACEBO COMPARATOR

Sham RIC+Standard medical treatment 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 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.

Procedure: Sham remote ischemic conditioning

Interventions

Remote ischemic conditioning 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.

RIC+Standard medical treatment

Sham remote ischemic conditioning PROCEDURE

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.

Sham RIC+Standard medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age ≥ 18 years, male or female
• \) 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)
• \) Pre-EVT NIHSS ≥ 6
• \) Premorbid mRS ≤ 2
• \) Written informed consent obtained from the patient or legally responsible person

You may not qualify if:

• \) Contraindication of endovascular thrombectomy
• \) 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
• \) Head CT showing cerebral hernia and midline displacement
• \) Pregnancy or lactation
• \) Previous remote ischemic conditioning therapy or similar treatment
• \) Severe hepatic and renal dysfunction
• \) Life expectancy of less than 3 months or inability to complete the study for other reasons
• \) Unwilling to be followed up or poor compliance
• \) Current or past participation in other clinical research, or participation in this study within 3 months prior to admission
• \) Other conditions that the researchers think make the patient unsuitable for the study

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of First Hospital of Jilin University

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 27, 2021
• Study Start: August 26, 2021
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

CN (1)