Ischemic Stroke
Conditions
Brief summary
This is a prospective, randomized, open label, blinded-end point, single-center study, aiming to investigate the effect of head down position in anterior circulation large vessel occlusion patients with successful recanalization after endovascular treatment.
Interventions
OTHERhead down position
-10° Trendelenburg
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Anterior circulation large vessel occlusion who received endovascular treatment within 24 hours of stroke onset; * National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment; * Successful recanalization (mTICI 2b-3) after endovascular treatment; * Cerebral circulation time based on DSA of the stroke side was slower than that of the healthy side after successful recanalization; * ASPECTS ≥ 6 on CT or DWI; * Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure; * Modified Rankin Scale score before stroke onset ≤ 1; * Signed informed consent by patient or their legally authorized representative.
Exclusion criteria
* Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage; * Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; * After recanalization, severe and sustained (i.e., \> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication; * More than four retrieval attempts in the same vessel; * Cardiac insufficiency (NYHA Class ≥II); * Pregnancy, plan to get pregnant or during lactation; * The estimated life expectancy is less than 6 months due to other serious diseases; * Other conditions unsuitable for this clinical study assessed by researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in National Institute of Health stroke scale (NIHSS) | 24±8 hours | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in cerebral edema | 24±8 hours | cerebral edema is determined by brain imaging |
| proportion of intraparenchymal hemorrhage (PH) | 24±8 hours | PH was defined as confluent bleeding occupying and causing mass effect |
| percentage of severe adverse events | 24±8 hours | — |
| all-cause mortality | 90±7 days | — |
| proportion of excellent functional outcome | 90±7 days | excellent functional outcome is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
| proportion of favorable functional outcome | 90±7 days | favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
| ordinal distribution of modified Rankin Score (mRS) | 90±7 days | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
| early neurological improvement (ENI) | 24±8 hours | ENI is defined as more than 8-point decrease in NIHSS or 0 NIHSS within 24±8 hours |
| changes in infarct volume | 24±8 hours | infarct volume is measured by diffused weighted imaging |
| Changes in National Institute of Health stroke scale (NIHSS) | 10±2 days | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome. |
| new stroke or other vascular event(s) | 90±7 days | — |
| proportion of sympomatic intracranial hemorrhage | 24±8 hours | sympomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage |
Other
| Measure | Time frame | Description |
|---|---|---|
| changes in serum biomarkers | 24±8 hours | serum biomarkers include MMP-9, TNF-alpha, IL-1beta, etc. |
| changes in cortical oxygen saturation | 24±8 hours | cortical oxygen saturation is determined by near infrared spectroscopy |
| changes in dynamic cerebral autoregulation (dCA) | 24±8 hours | 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.) |
Countries
China
Outcome results
None listed