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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ischemic post-conditioning group | Experimental | Mechanical thrombectomy combined with ischemic post-conditioning |
|
| 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 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct volume | Infarct volume at 72 hours after procedure | 72 hours after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The progression of infarct volume | Difference of infarct volume between baseline and 72 hours after procedure | Baseline and 72 hours after procedure |
| The proportion of functional independence at 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome (mortality at 90 days) | 90-day mortality | 90 days after procedure |
| Safety outcome (the proportion of symptomatic intracranial hemorrhage within 24 hours) | The proportion of symptomatic intracranial hemorrhage within 24 hours after procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Huanhu Hospital | Tianjin | 300350 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36523440 | Background | 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. | |
| 40889891 | Derived | Jiang X, Wu L, Liu S, Xu Y, Zhang B, Wang S, Luo L, Zhao W, Yao Y, Cao C, Zhao H, Ji X, Wei M. In situ ischemic postconditioning for acute ischemic stroke: preliminary exploratory study. J Neurointerv Surg. 2025 Aug 31:jnis-2025-024031. doi: 10.1136/jnis-2025-024031. Online ahead of print. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D015427 | Reperfusion Injury |
| 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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|
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)
| 90 days after procedure |
| The proportion of favorable outcome at 90 days | 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) | 90 days after procedure |
| The distribution of the mRS score at 90 days | 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) | 90 days after procedure |
| National Institute of Health Stroke Scale (NIHSS) score | NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits | 24 hours after procedure |
| The proportion of early neurological improvement | 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 | 24 hours after procedure |
| NIHSS score at 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 | 7 days after procedure/discharge |
| Recanalization rate | Recanalization rate at 24 hours after procedure (mTICI ≥2b) | 24 hours after procedure |
| Hemodynamic assessment | Hemodynamic assessment within 24 hours after procedure | Within 24 hours after procedure |
| Within 24 hours after procedure |
| Safety outcome (the proportion of intracranial hemorrhage within 24 hours) | The proportion of intracranial hemorrhage within 24 hours after procedure | Within 24 hours after procedure |
| Safety outcome (the proportion of malignant brain edema within 24 hours) | The proportion of malignant brain edema within 24 hours after procedure | Within 24 hours after procedure |
| Procedure-related complications | Vascular perforation/rupture, vessel dissection, severe vasospasm, rupture of the balloon used for post-conditioning | During the procedure |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |