Ischemic Stroke
Conditions
Brief summary
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.
Interventions
OTHERhead down position
the patient is positioned at a -20° 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 years; * Patients with acute large vessel occlusion scheduled for endovascular thrombectomy within 24 hours of symptom onset; * Baseline National Institute of Health Stroke Scale (NIHSS) ≥ 6; * Expected waiting time from randomization to femoral artery puncture is more than 30 minutes; * ASPECTS/pc-ASPECTS score ≥ 6 on baseline non-contrast CT or DWI; * 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; * Severe hypertension before randomization (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg); * Cardiac insufficiency (NYHA Class ≥II); * Pregnancy, plan to get pregnant or during lactation; * Patients at significant risk of aspiration (e.g., obvious nausea and vomiting); * 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 |
|---|---|---|
| early neurologic improvement (ENI) | 24±8 hours | ENI was defined as more than 4-point decrease in NIHSS within 24±8 hours; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion of modified Rankin Scale (mRS) 0-2 | 90±7 days | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
| proportion of symptomatic intracranial hemorrhage | 24±8 hours | symptomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage |
| proportion of intraparenchymal hemorrhage (PH) | 24±8 hours | PH was defined as confluent bleeding occupying and causing mass effect |
| all-cause mortality | 10±2 days | — |
| proportion of good collateral circulation status | during the first angiography examination | good collateral circulation status was defined as ASITN/SIR grade 3-4. |
| Change in National Institutes of Health Stroke Scale (NIHSS) | Immediately before endovascular treatment | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome. |
| Changes in cerebral infarct volume | 24±8 hours | infarct volume was measured by MRI-DWI |
| Changes in cerebral edema | 24±8 hours | change in cerebral edema was measured based on middle shift on CT or MRI |
| proportion of modified Rankin Scale (mRS) 0-1 | 90±7 days | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
| ordinal distribution of modified Rankin Scale (mRS) | 90±7 days | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
| new stroke or other vascular event(s) | 90±7 days | — |
| percentage of severe adverse events | 24±8 hours | — |
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