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Recent studies suggest that head-down positioning (HDP) intervention may improve outcomes in ischemic stroke. In the era of reperfusion therapy, a key protective strategy is to administer neuroprotective interventions before recanalization to reduce the loss of the ischemic penumbra, thereby salvaging more penumbral tissue after revascularization and ultimately improving clinical outcomes. Based on this concept, and considering the neuroprotective effects of HDP, the investigators hypothesize that HDP intervention prior to endovascular therapy (EVT) in patients with large vessel occlusion could improve clinical outcomes. This hypothesis is further supported by a recent clinical study (NCT03728738), which demonstrated that compared to a sitting up position (30°), a flat supine position (0°) before EVT significantly reduced the incidence of neurological deterioration prior to the procedure. Building on the above rationale, this trial aims to investigate the efficacy and safety of HDP intervention prior to EVT in patients with large vessel occlusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDP | Experimental | the HDP group receive -20° Trendelenburg prior endovascular treatment. |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| head down position | Other | the patient is positioned at a -20° Trendelenburg |
|
| Measure | Description | Time Frame |
|---|---|---|
| early neurologic improvement (ENI) | ENI was defined as more than 4-point decrease in NIHSS within 24±8 hours; | 24±8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of good collateral circulation status | good collateral circulation status was defined as ASITN/SIR grade 3-4. | during the first angiography examination |
| Change in National Institutes of Health Stroke Scale (NIHSS) |
| Measure | Description | Time Frame |
|---|---|---|
| changes in dynamic cerebral autoregulation (dCA) | dCA data include phase difference (the main parameter, determined as the phase shift angle ranging from 0° to 90°), gain (difference in the amplitude between CBFV and ABP), and the coherence function (indicates signal-to-noise ratio), which is determined according to previous report (Guo ZN, Guo WT, Liu J, et al. Changes in cerebral autoregulation and blood biomarkers after remote ischemic preconditioning.) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hui-Sheng Chen | Recruiting | Shenyang | None Selected | 110016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41778610 | Derived | Fei ZX, Dai YJ, Wang XH, Chen HS. Head Down Position Before Endovascular Treatment for Large Vessel Occlusion: Clinical Trial Design. J Am Heart Assoc. 2026 Mar 17;15(6):e046853. doi: 10.1161/JAHA.125.046853. Epub 2026 Mar 4. |
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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 |
|---|---|
| D018475 | Head-Down Tilt |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
| Immediately before endovascular treatment |
| Change in National Institutes of Health Stroke Scale (NIHSS) | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome. | 24±8 hours |
| Changes in cerebral infarct volume | infarct volume was measured by MRI-DWI | 24±8 hours |
| Changes in cerebral edema | change in cerebral edema was measured based on middle shift on CT or MRI | 24±8 hours |
| Change in National Institutes of Health Stroke Scale (NIHSS) | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome. | 10±2 days |
| proportion of modified Rankin Scale (mRS) 0-1 | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome | 90±7 days |
| proportion of modified Rankin Scale (mRS) 0-2 | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome | 90±7 days |
| ordinal distribution of modified Rankin Scale (mRS) | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome | 90±7 days |
| new stroke or other vascular event(s) | 90±7 days |
| percentage of severe adverse events | 24±8 hours |
| proportion of symptomatic intracranial hemorrhage | symptomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage | 24±8 hours |
| proportion of intraparenchymal hemorrhage (PH) | PH was defined as confluent bleeding occupying and causing mass effect | 24±8 hours |
| all-cause mortality | 10±2 days |
| 24±8 hours |
| changes in cortical oxygen saturation | cortical oxygen saturation is determined by near infrared spectroscopy | 24±8 hours |
| changes in serum biomarkers | serum biomarkers include MMP-9, TNF-alpha, IL-1beta, etc. | 24±8 hours |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |