RecruitingPhase 2NCT06545734

Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion

Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion: A Randomized Controlled Pilot Trial

Sponsor

Tianjin Huanhu Hospital

Enrollment

60 participants

Start Date

Feb 5, 2023

Study Type

INTERVENTIONAL

Conditions

Stroke, Acute Neuroprotection Ischemic Conditioning

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Ischemic stroke confirmed by CT or MRI.
Large vessel occlusion confirmed by CTA or MRA, including the intracranial internal 3. carotid artery (ICA) and middle cerebral artery (MCA M1/M2).
\. Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy.
\. The patient or legally authorized representative has signed an informed consent form.

Exclusion Criteria5

Inability to perform an MRI or CT scan for any reason.
Presence of any condition that would interfere with neurological assessment or any psychiatric disorders.
Stroke onset accompanied by seizures, resulting in the inability to obtain an accurate NIHSS baseline.
Pregnancy.
Presence of other serious, advanced, or terminal illnesses.

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Interventions

PROCEDUREDirect Ischemic Post-conditioning

After thrombectomy, the balloon was inflated to a pressure of no more than 4 atm at the occlusion site to block blood flow for 2 minutes, as confirmed by angiography. The balloon was then deflated, allowing blood flow to resume for 2 minutes. These steps were repeated four times.

PROCEDUREEndovascular therapy

Thrombectomy alone.