Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES4)

Ischemic Stroke Clinical Trial

Official title:

Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES3): a Prospective, Randomized, Open Label, Blinded-end Point, Single-center Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06313710
• Other study ID #: Y (2024) 058
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 10, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: April 2024
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 0.06 seconds 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;

• 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.

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Other:
• head down position
-10° Trendelenburg

Locations

Country	Name	City	State
China	Department of Neurology, General Hospital of Northern Theater Command	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.)	24±8 hours
Other	changes in cortical oxygen saturation	cortical oxygen saturation is determined by near infrared spectroscopy	24±8 hours
Other	changes in serum biomarkers	serum biomarkers include MMP-9, TNF-alpha, IL-1beta, etc.	24±8 hours
Primary	Changes in National Institute 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
Secondary	proportion of excellent functional outcome	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	90±7 days
Secondary	proportion of favorable functional outcome	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	90±7 days
Secondary	ordinal distribution of modified Rankin Score (mRS)	The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome	90±7 days
Secondary	early neurological improvement (ENI)	ENI is defined as more than 8-point decrease in NIHSS or 0 NIHSS within 24±8 hours	24±8 hours
Secondary	changes in infarct volume	infarct volume is measured by diffused weighted imaging	24±8 hours
Secondary	changes in cerebral edema	cerebral edema is determined by brain imaging	24±8 hours
Secondary	Changes in National Institute 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
Secondary	new stroke or other vascular event(s)		90±7 days
Secondary	proportion of sympomatic intracranial hemorrhage	sympomatic intracranial hemorrhage is defined as a NIHSS increase =4 caused by intracranial hemorrhage	24±8 hours
Secondary	proportion of intraparenchymal hemorrhage (PH)	PH was defined as confluent bleeding occupying and causing mass effect	24±8 hours
Secondary	percentage of severe adverse events		24±8 hours
Secondary	all-cause mortality		90±7 days