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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ischemic post-conditioning group | Experimental | Mechanical thrombectomy combined with ischemic post-conditioning |
|
| Control group | Sham Comparator | Mechanical thrombectomy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical thrombectomy combined with ischemic post-conditioning | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct volume at 24 hours | Infarct volume on MRI-DWI at 24 hours after randomization | 24 hours after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of infarct volume between baseline and 24 hours | Difference of infarct volume on MRI-DWI between baseline and 24 hours after randomization | Baseline and 24 hours after randomization |
| Progression of perfusion defect from baseline to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome (mortality at 90 days) | 90-day mortality | 90 days after randomization |
| Safety outcome (the proportion of symptomatic intracranial hemorrhage within 24 hours) | The proportion of symptomatic intracranial hemorrhage within 24 hours after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, MD | Contact | 010-83198952 | jixm@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Huanhu Hospital | Recruiting | Tianjin | Tianjin Municipality | 300350 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37497674 | Background | Wu L, Wei M, Zhang B, Zhang B, Chen J, Wang S, Luo L, Liu S, Li S, Ren C, Hess DC, Song H, Zhao W, Ji X. Safety and Tolerability of Direct Ischemic Postconditioning Following Thrombectomy for Acute Ischemic Stroke. Stroke. 2023 Sep;54(9):2442-2445. doi: 10.1161/STROKEAHA.123.044060. Epub 2023 Jul 27. | |
| 36523440 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D057775 | Ischemic Postconditioning |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Mechanical thrombectomy alone | Procedure | Successful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning. |
|
The volume difference of Tmax > 6 s from baseline to 24 hours after randomization |
| Baseline and 24 hours after randomization |
| Progression of infarct volume between 2 hours and 24 hours | Difference of infarct volume on MRI-DWI between 2 h after randomization and 24 h after randomization | 2 hours after randomization and 24 hours after randomization |
| Infarct volume at 5 days/at discharge | Infarct volume on CT/MRI-FLAIR at 5 days after randomization/at discharge | 5 days after randomization or at discharge |
| The proportion of functional independence at 90 days | 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) | 90 days after randomization |
| The proportion of favorable outcome at 90 days | 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) | 90 days after randomization |
| The distribution of mRS score at 90 days | 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) | 90 days after randomization |
| National Institute of Health Stroke Scale (NIHSS) score at 24 hours | NIHSS score at 24 hours after randomization; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits | 24 hours after randomization |
| The proportion of early neurological improvement | 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 | Baseline and 24 hours after randomization |
| National Institute of Health Stroke Scale (NIHSS) score at 5 days/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 | 5 days after randomization or at discharge |
| Recanalization rate at 24 hours | Recanalization rate at 24 hours after randomization (eTICI 2b-3) | 24 hours after randomization |
| Cerebral blood flow velocity of the culprit middle cerebral artery at 24 hours after randomization. | Cerebral blood flow will be assessed by transcranial Doppler ultrasound at 24 hours after randomization | 24 hours after randomization |
| Within 24 hours after randomization |
| Safety outcome (the proportion of intracranial hemorrhage within 24 hours) | The proportion of intracranial hemorrhage within 24 hours after randomization | Within 24 hours after randomization |
| Safety outcome (the proportion of malignant brain edema within 24 hours) | The proportion of malignant brain edema within 24 hours after randomization | Within 24 hours after randomization |
| Procedure-related complications | Vascular perforation/rupture, vessel dissection, severe vasospasm, rupture of the balloon used for post-conditioning | During the procedure |
| Wu L, Zhang B, Zhao W, Ji X, Wei M. Ischemic post-conditioning in acute ischemic stroke thrombectomy: A phase-I duration escalation study. Front Neurosci. 2022 Dec 8;16:1054823. doi: 10.3389/fnins.2022.1054823. eCollection 2022. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |