Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion: A Randomized Controlled Pilot Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stroke, Acute
- Sponsor
- Tianjin Huanhu Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Final Infarct volume
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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:
- Is direct IPostC effective for acute stroke patients with large vessel occlusion?
- 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.
Investigators
Ming Wei
Chief Physician
Tianjin Huanhu Hospital
Eligibility Criteria
Inclusion Criteria
- •Ischemic stroke confirmed by CT or MRI.
- •Large vessel occlusion confirmed by CTA or MRA, including the intracranial internal
- •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 Criteria
- •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.
- •Presence of other serious, advanced, or terminal illnesses.
Outcomes
Primary Outcomes
Final Infarct volume
Time Frame: 24(-6/+12) hours after procedure
Infarct volume at 24 (-6/+12) hours postoperatively
Infarct Volume Growth
Time Frame: 24(-6/+12) hours after procedure
Infarct volume at 24 (-6/+12) hours - Infarct volume at baseline; Infarct volume at 24 (-6/+12) hours - Infarct volume at 2 hours
Secondary Outcomes
- Change in NIHSS between baseline and 2 hours(2 hours after procedure)
- Change in NIHSS between baseline and 24 hours(24 hours after procedure)
- Functional Independence at 90 days(90 days after randomization)
- Blood brain barrier permeability at 72 hours(72 hours after procedure)
- Functional Independence at 5 days or discharge(5 days or at discharge after randomization)