Clinical trial NCT06545734: Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion
Official title: Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stroke, Acute
Neuroprotection
Ischemic Conditioning
Keywords: Stroke, Acute; Large Vessel Occlusion; Neuroprotection
Lead sponsor: Tianjin Huanhu Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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 criteria: 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).

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

5. 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.

Primary outcomes:
measure: Final Infarct volume
timeFrame: 24(-6/+12) hours after procedure
measure: Infarct Volume Growth
timeFrame: 24(-6/+12) hours after procedure
Secondary outcomes:
measure: Change in NIHSS between baseline and 2 hours
timeFrame: 2 hours after procedure
measure: Change in NIHSS between baseline and 24 hours
timeFrame: 24 hours after procedure
measure: Functional Independence at 90 days
timeFrame: 90 days after randomization
measure: Functional Independence at 5 days or discharge
timeFrame: 5 days or at discharge after randomization
measure: Blood brain barrier permeability at 72 hours
timeFrame: 72 hours after procedure
Other outcomes:
measure: Difference in Peripheral circulating immune cells counts
timeFrame: 1, 3 and 5 days after procedure
measure: Difference in lymphocyte phenotyping
timeFrame: PBMC isolated from peripheral venous blood at 24 hours
measure: Difference in expression of genes associated with T cell polarization
timeFrame: PBMC isolated from peripheral venous blood at 24 hours
measure: Difference in cytokines and chemokines associated with T cell polarization and recruitment
timeFrame: Serum isolated from peripheral venous blood at 24 hours
Locations:
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
Study officials:
References: