Endovascular Treatment and RIPC in Acute Ischemic Stroke

NCT04581759 | Unknown DMC

• 1 other identifier: XJTU1AF-CRF-2020-015
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Endovascular treatment（ET）is an effective therapy for acute ischemic stroke(AIS) with great vessel obstruction. However, acute complications such as high postoperative perfusion injury, hemorrhagic transformation and restenosis resulted in functional independence in only about 50% of patients 90 days after interventional surgery. Therefore, it is very important to protect the neurologic function after emergency endovascular treatment. The investigators' previous studies have shown that combined with intravenous thrombolytic therapy and remote postconditioning（RIPC）can significantly improve the neurological impairment and short-term and long-term prognosis in patients with acute stroke. In this multicenter, randomized controlled trial, the investigators assumed patients with acute ischemic stroke who had successfully revascularization after ET might benefit from RIPC as well. Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after ET. The primary endpoint measure was the proportion of patients with a favorable recovery of nerve function deficient assessed by Modified Rankin Scale （mRS≤2） 90 days after surgery. Secondary endpoints included the following: (1) Symptom endpoints: Neurological intelligence and function scores, postoperative hemorrhagic transformation rate, etc. (2) Blood index test: postoperative inflammatory factors, neuron-specific enolase (NSE) and other indicators. (3) Imaging endpoints: MRI-FLAIR , TCD, etc.

Conditions

Acute Ischemic Stroke; Endovascular Treatment

Outcome Measures

Primary Outcomes (1)

• Modified Rankin scale (mRS)

  The percentage of patients with a favorable outcome from baseline at 90 days and 180 days postoperatively, defined as a score of 0 or 2 on the modified Rankin scale (mRS)（Notes:mRS score from 0-6, higher scores mean worse outcome）

  7days, 90 days and 180 days after the surgery and at discharge

Secondary Outcomes (15)

• The change of NIHSS score

  7days, 90 days and 180 days after the surgery and at discharge

• The change of Barthel Index

  7days, 90 days and 180 days after the surgery and at discharge

• The change of Montreal Cognitive Assessment (MoCA) score

  7days, 90 days and 180 days after the surgery and at discharge

• The change of MMSE score

  7days, 90 days and 180 days after the surgery and at discharge

• The change of inflammatory indicators

  before ET, 24 hours and 7 days after the surgery

Study Arms (2)

RIPC

EXPERIMENTAL

Patients in the RIPC group not only receive foundational treatment but also have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm using a RIPC device (IPC-906X; Beijing Renqiao Institute of Neuroscience, Beijing, China) after endovascular treatment while in-hospital.

Device: RIPC device (IPC-906X); Drug: foundational treatment

foundational treatment group (FT)

SHAM COMPARATOR

Patients in the FT group only receive foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin or/and clopidogrel,100-300mg/d) and lipid-lowering (atorvastatin 20-60mg/d,rosuvastatin 10-20mg/d) drugs, during the study period without remote ischemic postconditioning after endovascular treatment.

Drug: foundational treatment

Interventions

RIPC device (IPC-906X) DEVICE

Patients in the RIPC group will have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm twice a day after Mechanical Thrombectomy.

RIPC

foundational treatment DRUG

foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin or/and clopidogrel ) and lipid-lowering (statins) drugs

RIPC; foundational treatment group (FT)

Eligibility Criteria

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

You may qualify if:

• acute ischemic stroke（AIS） patients with large vessel occlusion (internal carotid artery system and vertebral basilar artery system) within 24 hours after onset, endovascular treatment (mechanical thrombotomy, intra-arterial thrombolysis, balloon dilatation or stent angioplastyand) successful opening were performed, and the definition of successful opening was defined by Modified Thrombolysis standard \[Modified Thrombolysis in Cerebral infarction, mTICI\]≥ 2B，The standards of endovascular interventional treatment are in line with the indications and contraindications formulated in the Chinese Guidelines for the Early Treatment of Acute Ischemic Stroke 2018；
• Modified Rankin scale score (mRS) ≤1 before onset:
• The Alberta Stroke Program Early CT score (ASPECTS)≥6 on admission;
• National Institute of Health Stroke Scale (NIHSS) score ≥6 on admission;
• Provision of written informed consent.

You may not qualify if:

• CT or MRI scan showed significant midline deviation and the mass effect;
• Glasgow(GCS) score ≤8 on admission;
• failure to accomplish 3-months and 6-months follow up;
• Severe cardiac, liver, or kidney disease, malignancy, severe coagulation dysfunction, severe anemia and systemic organ dysfunction;
• Pregnant or nursing women, or patients with moderate to severe mental disorders or dementia;
• Severe soft tissue injuries, fractures, thrombosis and other known peripheral vascular lesions of the upper limbs，active visceral hemorrhage, acute stage of fundus hemorrhage, cerebral aneurysm or cerebral arteriovenous malformation, and other unsuitable for bilateral upper arm compression.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• Shaanxi Provincial People's Hospital: collaborator
• Xijing Hospital: collaborator
• Tang-Du Hospital: collaborator
• Xi'an No.3 Hospital: collaborator
• Xi'an Gaoxin Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Guogang Luo, MD

CONTACT

0086-13991974085; lguogang@163.com

Meng Wei, MD

CONTACT

0086-15991748135; 67183723@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: October 9, 2020
• Study Start: April 12, 2021
• Primary Completion: April 30, 2023
• Study Completion: October 30, 2023
• Last Updated: May 10, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12/31/2023, for 1 year

Locations

CN (1)