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This multicenter, prospective, observational diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment. The study aims to determine whether impaired cerebral autoregulation during thrombectomy can serve as an ultra-early biomarker for predicting futile recanalization in patients with acute ischemic stroke.
Acute ischemic stroke (AIS) is the leading cause of death and disability in China. Landmark randomized controlled trials have demonstrated the benefit of endovascular therapy for patientswith acute stroke due to large-vessel occlusion. Despite successful recanalization rates exceeding 80%, more than half of patients fail to achieve functional independence following thrombectomy a phenomenon termed futile recanalization. Ultra-early identification of futile recanalization is critical for guiding individualized treatment strategies. Timely recognition of at-risk patients may enable targeted interventions - such as intra-arterial thrombolysis, rescue therapy, and neuroprotective measures that could potentially reverse unfavorable outcomes or mitigate adverse events. Monitoring cerebral autoregulation (CA) function during thrombectomy represents a promising approach for the ultra-early prediction of futile recanalization. This multicenter, prospective, observational diagnostic accuracy study aims to validate the hypothesis that intraoperative CA monitoring during thrombectomy can predict futile recanalization. A total of 129 participants will be enrolled and divided into a modeling cohort and a validation cohort. Participants will undergo face-to-face assessments at 24 ± 12 hours, 48 ± 12 hours, and 7 ± 3 days post-enrollment (or at discharge). A follow-up assessment will be conducted via telephone or in-person interview at 90 ± 7 days post-enrollment. The primary endpoints include the sensitivity, specificity, and area under the receiver operating characteristic curve of impaired CA for predicting futile recanalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebral autoregulation monitoring cohort | The consecutively enrolled participants undergoing thrombectomy for acute ischemic stroke. Intraoperative cerebral autoregulation will be assessed using near-infrared spectroscopy (NIRS)-based cerebral oxygen saturation monitoring combined with continuous blood pressure monitoring (noninvasive or invasive). This cohort will be used to develop the predictive and validate model for futile recanalization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diagnostic accuracy study | Diagnostic Test | Cerebral autoregulation is assessed intraoperatively during thrombectomy using near-infrared spectroscopy (NIRS)-derived cerebral oxygen saturation combined with continuous noninvasive or invasive arterial blood pressure monitoring. The correlation between cerebral oxygen saturation and arterial blood pressure is analyzed to quantify cerebral autoregulation status. This monitoring is performed as part of routine clinical care and does not constitute an additional research intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity, specificity and area under the receiver operating characteristic curve for percentage of Modified Rankin scale 0-2 | "Futile recanalization" is defined as a poor neurological prognosis (90-day Modified Rankin scale > 2) in patients with acute large vessel occlusion ischemic stroke who have achieved good recanalization grade (mTICI≥2b) after endovascular treatment. The sensitivity, specificity and area under the receiver operating characteristic curve of cerebral autoregulation coefficient in predicting the percentage of mRS scale 0-2 (Modified Rankin scale [ranging from 0 (normal) to 6 (death) were calculated.](streamdown:incomplete-link) | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity, specificity and area under the receiver operating characteristic curve for early neurological improvement | The sensitivity, specificity and area under the receiver operating characteristic curve of cerebral autoregulation coefficient in predicting early neurological improvement were calculated. "Early neurological improvement" is defined as an improvement of 8 or more points in NIHSS score or a decrease to 0-1 within 24 hours after recanalization. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute ischemic stroke due to anterior circulation large-vessel occlusion who undergo mechanical thrombectomy within 24 hours of the last known normal time, achieving successful recanalization (mTICI ≥ 2b).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zidong Li | Contact | 010-63925615 | walx592815088@163.com | |
| Shen Li | Contact | 010-63925616 | lishen@mail.ccmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shen Li | Beijing Shijitan Hospital, Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
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| Day 1 |
| The First Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | China |
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| Dalian Municipal Central Hospital | Not yet recruiting | Dalian | Liaoning | China |
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| Weifang People's Hospital Affiliated to Weifang Medical University | Recruiting | Weifang | Shandong | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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