Acute Ischemic Stroke, Reperfusion Injury
Conditions
Brief summary
Ischemic post-conditioning is a neuroprotective strategy attenuating reperfusion injury in animal stroke models. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. This study aims to assess the infarct volume after ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.
Interventions
Ischemic post-conditioning will be applied after successful recanalization of the culprit artery by thrombectomy. Ischemic post-conditioning consists of briefly repeated four cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.
Sponsors
Capital Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years; * Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture; * Previous mRS ≤ 2; * Baseline NIHSS ≥ 6; * Baseline ASPECTS ≥ 6; * With an occlusion of unilateral middle cerebral artery M1 segment/distal intracranial carotid artery; * Successful recanalization (mTICI ≥ 2b) after thrombectomy confirmed by DSA; * Written informed consent provided by the patients or their legal relatives.
Exclusion criteria
* Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia; * Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning; * Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy; * \> 2 times balloon dilations as rescue therapy due to angioplasty during thrombectomy; * Moderate/severe residual stenosis (≥ 50%) in the offending artery after thrombectomy; * Patients with contraindications to MRI; * Other conditions that the investigator considered inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct volume | 72 hours after procedure | Infarct volume at 72 hours after procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic assessment | Within 24 hours after procedure | Hemodynamic assessment within 24 hours after procedure |
| The distribution of the mRS score at 90 days | 90 days after procedure | The distribution of the mRS score at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death) |
| National Institute of Health Stroke Scale (NIHSS) score | 24 hours after procedure | NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits |
| The proportion of early neurological improvement | 24 hours after procedure | NIHSS 0-2 or ≥8 lower than baseline NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits |
| NIHSS score at 7 days after procedure/discharge | 7 days after procedure/discharge | NIHSS score at 7 days after procedure/discharge; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits |
| Recanalization rate | 24 hours after procedure | Recanalization rate at 24 hours after procedure (mTICI ≥2b) |
| The proportion of functional independence at 90 days | 90 days after procedure | The modified Rankin Scale (mRS) score of 0-2 at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death) |
| The progression of infarct volume | Baseline and 72 hours after procedure | Difference of infarct volume between baseline and 72 hours after procedure |
| The proportion of favorable outcome at 90 days | 90 days after procedure | The mRS score of 0-3 at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety outcome (mortality at 90 days) | 90 days after procedure | 90-day mortality |
| Safety outcome (the proportion of symptomatic intracranial hemorrhage within 24 hours) | Within 24 hours after procedure | The proportion of symptomatic intracranial hemorrhage within 24 hours after procedure |
| Safety outcome (the proportion of malignant brain edema within 24 hours) | Within 24 hours after procedure | The proportion of malignant brain edema within 24 hours after procedure |
| Procedure-related complications | During the procedure | Vascular perforation/rupture, vessel dissection, severe vasospasm, rupture of the balloon used for post-conditioning |
| Safety outcome (the proportion of intracranial hemorrhage within 24 hours) | Within 24 hours after procedure | The proportion of intracranial hemorrhage within 24 hours after procedure |
Countries
China
Outcome results
None listed