Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients Within 6-24 Hours of Symptom Onset

Capital Medical University1 site in 1 country120 target enrollmentOctober 27, 2021

ConditionsStroke Endovascular Treatment Neuroprotection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Capital Medical University
Enrollment: 120
Locations: 1
Primary Endpoint: Early neurologic improvement (ENI) at 24 hours
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficiency of normobaric hyperoxia combined with endovascular treatment for acute ischemic stroke patients with stroke onset 6-24 hours.

Registry

clinicaltrials.gov

Start Date

October 27, 2021

End Date

October 15, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Capital Medical University

Responsible Party

Principal Investigator

Ji Xunming,MD,PhD

Principal Investigator

Capital Medical University

Eligibility Criteria

Inclusion Criteria

•Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1/M2-segment of the MCA;
•Stroke symptom onset has been more than 6 hours but not more than 24 hours,and imaging confirmed the existenceof ischemic penumbra;
•NIHSS score≥6;
•Alberta Stroke Program Early CT score (ASPECTS) of 6-10 on non- contrast CT;
•(Level of consciousness) NIHSS score of 0 or 1
•mRS score was 0-1 before stroke;
•Informed consent obtained;

Exclusion Criteria

•Rapid improvement in neurological status to an NIHSS \< 6 or evidence of vessel recanalization prior to randomization;
•Seizures at stroke onset;
•Intracranial hemorrhage;
•Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication)necessary to reduce blood pressure to these limits;
•Symptoms rapidly improving;
•Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
•Platelet count of less than 100,000 per cubic millimeter;
•CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere);
•severe hepatic or renal dysfunction;
•active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;

Outcomes

Primary Outcomes

Early neurologic improvement (ENI) at 24 hours

Time Frame: 24 ± 12 hours

ENI was defined as percent change NIHSS≥30%; Percent change NIHSS was defined as \[(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score\];

Secondary Outcomes

Mortality(90 ± 14 days after randomization)
modified Rankin Scale score (mRS)(90 ± 14 days after randomization)
Revascularization on 24-hour follow-up imaging(24 ± 12 hours hours after randomization)
Early neurologic deterioration(24 ± 12 hours after randomization)
Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours(24 ± 12 hours after randomization)
Symptomatic Intracerebral Hemorrhage(24± 12 hours hours after randomization)
Stroke recurrence(90 ± 14 days，180 ± 30 days after randomization)
Cerebral infarct volume(36 ± 12 hours after randomization)
The 5-level EuroQol five dimensions questionnaire（EQ-5D-5L）score(90 ± 14 days after randomization)
Delta NIHSS(24 ± 12 hours after randomization)
National Institutes of Health Stroke Scale(NIHSS) Score(4 hours ± 15 minutes, 24 ± 12 hours; 7 ± 2 days after randomization)
Barthel Index (BI)(90 ± 14 days after randomization)
Percent change NIHSS(24 ± 12 hours after randomization)