Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion
NCT Number: NCT06545734
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Stroke, Acute|Neuroprotection|Ischemic Conditioning
Interventions: PROCEDURE: Direct Ischemic Post-conditioning|PROCEDURE: Endovascular therapy
Sponsor: Tianjin Huanhu Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02-05
Completion Date: 2024-09
Locations: Tianjin Huanhu Hospital, Tianjin, Tianjin, 300070, China

Summary:
The goal of this clinical trial is to determine if direct ischemic post-conditioning (IPostC) can alleviate ischemic-reperfusion injury (I/R) in patients who have undergone endovascular thrombectomy (EVT). Additionally, the study aims to explore the underlying mechanisms of direct IPostC.

The primary questions this trial seeks to answer are:

1. Is direct IPostC effective for acute stroke patients with large vessel occlusion?
2. What are the underlying mechanisms of direct IPostC?

Participants will be randomly assigned to one of two groups: an EVT alone group or an EVT plus direct IPostC group. Direct IPostC will be administered immediately after EVT through four cycles of mechanical interruptions of reperfusion. We will evaluate outcomes based on final infarct volume, infarct volume growth, clinical parameters, and I/R-related imaging and laboratory biomarkers. Additionally, an exploratory multi-omics analysis will be conducted to uncover the detailed mechanisms of direct IPostC.

Primary Outcome Measures: Final Infarct volume, Infarct volume at 24 (-6/+12) hours postoperatively, 24(-6/+12) hours after procedure|Infarct Volume Growth, Infarct volume at 24 (-6/+12) hours - Infarct volume at baseline; Infarct volume at 24 (-6/+12) hours - Infarct volume at 2 hours, 24(-6/+12) hours after procedure
Secondary Outcome Measures: Change in NIHSS between baseline and 2 hours, NIHSS at 2 hours - NIHSS at baseline, 2 hours after procedure|Change in NIHSS between baseline and 24 hours, NIHSS at 24 hours - NIHSS at baseline, 24 hours after procedure|Functional Independence at 90 days, The proportion of mRS 0-2 at 90 days, 90 days after randomization|Functional Independence at 5 days or discharge, The proportion of mRS 0-2 at 5 days or discharge, 5 days or at discharge after randomization|Blood brain barrier permeability at 72 hours, This is quantified by ktrans value through MR, 72 hours after procedure
Other Outcome Measures: Difference in Peripheral circulating immune cells counts, Immune cell counts acquired from CBC., 1, 3 and 5 days after procedure|Difference in lymphocyte phenotyping, CD4 T cells, CD8 T cells, B cells, NK cells count by flow cytometry., PBMC isolated from peripheral venous blood at 24 hours|Difference in expression of genes associated with T cell polarization, TBX21, GATA3, RORC and FOXP3, PBMC isolated from peripheral venous blood at 24 hours|Difference in cytokines and chemokines associated with T cell polarization and recruitment, IL-1β, IL-18, IL-17, IL-10, IFN-γ, TNF-α, IL-6, CX3CL1, CXCL10, CCL17, Serum isolated from peripheral venous blood at 24 hours