Ischemic Conditioning, Neuroprotection, Stroke, Acute
Conditions
Keywords
Stroke, Acute; Large Vessel Occlusion; Neuroprotection
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.
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.
Sponsors
Tianjin Huanhu Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct Volume Growth | 48 (-12/+24) hours after randomization | Infarct volume at 48 (-12/+24) hours - Infarct volume at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Final infarct volume | 48 (-12/+24) hours after randomization | Infarct volume at 48 (-12/+24) hours post-randomization. |
| Immediate postprocedural infarct volume | Within 2 hours after procedure. | Infarct volume measured within 2 hours after procedure. |
| Difference in modified Rankin Scale distribution | At 90 days post-randomization. | The modified Rankin Scale (mRS) is a 7-point ordinal scale ranging from 0 (no disability) to 6 (death). Higher scores indicate worse outcomes. The distribution of mRS scores (0-6) will be compared between treatment groups. |
| Difference in modified Rankin Scale of 0-1 | At 90 days post-randomization. | The modified Rankin Scale (mRS) is a 7-point ordinal scale ranging from 0 (no disability) to 6 (death). Higher scores indicate worse outcomes. The proportion of mRS 0-1 will be compared between treatment groups. |
| Difference in modified Rankin Scale of 0-2 | At 90 days post-randomization. | The modified Rankin Scale (mRS) is a 7-point ordinal scale ranging from 0 (no disability) to 6 (death). Higher scores indicate worse outcomes. The proportion of mRS 0-2 will be compared between treatment groups. |
| Occurrence of early neurological improvement | Within 24 hours post-randomization. | The National Institutes of Health Stroke Scale (NIHSS) is a 42-point ordinal scale ranging from 0 (no stroke symptoms) to 42 (severe stroke). Higher scores indicate worse neurological deficits. Early neurological improvement is defined as a reduction in NIHSS score by ≥8 points. |
| Longitudinal Change of NIHSS Scores | At 24 hours, 3 days, and 5-7 days post-randomization or at discharge. | The National Institutes of Health Stroke Scale (NIHSS) is a 42-point ordinal scale ranging from 0 (no stroke symptoms) to 42 (severe stroke). Higher scores indicate worse neurological deficits. NIHSS scores will be serially assessed at specified intervals. |
Countries
China
Outcome results
None listed