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

Tianjin Huanhu Hospital

Status and phase: Enrolling; Phase 2

Conditions: Stroke, Acute; Neuroprotection; Ischemic Conditioning

Treatments: Procedure: Endovascular therapy; Procedure: Direct Ischemic Post-conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT06545734

TJHH-2024-WM28

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Ischemic stroke confirmed by CT or MRI.

2. Large vessel occlusion confirmed by CTA or MRA, including the intracranial internal 3. carotid artery (ICA) and middle cerebral artery (MCA M1/M2).

3. Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy.

4. The patient or legally authorized representative has signed an informed consent form.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Endovascular therapy

Active Comparator group

Treatment:

Procedure: Endovascular therapy

Endovascular therapy plus direct ischemic post-conditioning

Experimental group

Treatment:

Procedure: Direct Ischemic Post-conditioning

Procedure: Endovascular therapy