Acute Ischemic Stroke
Conditions
Brief summary
Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. 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. The purpose of this study is to further determine the efficacy and safety of 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 achieve by thrombectomy. Ischemic post-conditioning consists of briefly repeated 4 cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.
PROCEDUREMechanical thrombectomy alone
Successful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years; 2. Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture; 3. Previous mRS ≤ 2; 4. Baseline NIHSS ≥ 6; 5. Baseline ASPECTS ≥ 6; 6. Unilateral middle cerebral artery occlusion with or without ipsilateral internal carotid artery occlusion; 7. Successful recanalization after mechanical thrombectomy (eTICI 2b-3); 8. Written informed consent provided by the patients or their legal relatives.
Exclusion criteria
1. Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia; 2. Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning; 3. Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus; 4. Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy; 5. \> 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy; 6. Patients with contraindications to MRI; 7. Other conditions that the investigator considered inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct volume at 24 hours | 24 hours after randomization | Infarct volume on MRI-DWI at 24 hours after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of functional independence at 90 days | 90 days after randomization | The modified Rankin Scale (mRS) score of 0-2 at 90 days after randomization; 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 at 24 hours | 24 hours after randomization | NIHSS score at 24 hours after randomization; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits |
| The proportion of early neurological improvement | Baseline and 24 hours after randomization | NIHSS 0-2 or ≥ 8 lower than baseline NIHSS score at 24 hours after randomization; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits |
| National Institute of Health Stroke Scale (NIHSS) score at 5 days/at discharge | 5 days after randomization or at discharge | NIHSS score at 5 days after randomization/at discharge; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits |
| Recanalization rate at 24 hours | 24 hours after randomization | Recanalization rate at 24 hours after randomization (eTICI 2b-3) |
| Cerebral blood flow velocity of the culprit middle cerebral artery at 24 hours after randomization. | 24 hours after randomization | Cerebral blood flow will be assessed by transcranial Doppler ultrasound at 24 hours after randomization |
| Progression of infarct volume between baseline and 24 hours | Baseline and 24 hours after randomization | Difference of infarct volume on MRI-DWI between baseline and 24 hours after randomization |
| Progression of perfusion defect from baseline to 24 hours | Baseline and 24 hours after randomization | The volume difference of Tmax \> 6 s from baseline to 24 hours after randomization |
| Progression of infarct volume between 2 hours and 24 hours | 2 hours after randomization and 24 hours after randomization | Difference of infarct volume on MRI-DWI between 2 h after randomization and 24 h after randomization |
| Infarct volume at 5 days/at discharge | 5 days after randomization or at discharge | Infarct volume on CT/MRI-FLAIR at 5 days after randomization/at discharge |
| The proportion of favorable outcome at 90 days | 90 days after randomization | The mRS score of 0-3 at 90 days after randomization; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death) |
| The distribution of mRS score at 90 days | 90 days after randomization | The distribution of the mRS score at 90 days after randomization; 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 (the proportion of intracranial hemorrhage within 24 hours) | Within 24 hours after randomization | The proportion of intracranial hemorrhage within 24 hours after randomization |
| Safety outcome (the proportion of malignant brain edema within 24 hours) | Within 24 hours after randomization | The proportion of malignant brain edema within 24 hours after randomization |
| Procedure-related complications | During the procedure | Vascular perforation/rupture, vessel dissection, severe vasospasm, rupture of the balloon used for post-conditioning |
| Safety outcome (mortality at 90 days) | 90 days after randomization | 90-day mortality |
| Safety outcome (the proportion of symptomatic intracranial hemorrhage within 24 hours) | Within 24 hours after randomization | The proportion of symptomatic intracranial hemorrhage within 24 hours after randomization |
Countries
China
Contacts
Primary ContactXunming Ji, MD
Outcome results
None listed