Acute ischemic stroke due to anterior circulation large vessel occlusion
Conditions
Interventions
Experimental group:Intra-arterial bolus followed by continuous intravenous infusion of glyceryl trinitrate (GTN)
Control group:Intra-arterial bolus followed by continuous intravenous infusion of normal saline
Sponsors
Beijing Luhe Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.Clinical diagnosis of anterior circulation acute ischemic stroke, with acute occlusion located in the intracranial segment of the internal carotid artery (ICA), or middle cerebral artery (MCA) M1 segment; 3.Stroke onset within 24 hours; 4.Baseline NIHSS score >= 6; 5.Latest brain imaging confirming ASPECTS >= 6; 6.Patients presenting within 6–16 hours must meet mismatch criteria: infarct core volume = 1.8, and mismatch volume >15 mL (DEFUSE-3 criteria); or NIHSS >= 10 with infarct core volume = 20 with infarct core volume <= 51 cm^3 (DAWN criteria). Patients with onset of stroke for 16–24 hours must satisfy DAWN mismatch criteria; 7.Planned to undergo intravenous thrombolysis with bridging endovascular mechanical thrombectomy or direct endovascular mechanical thrombectomy; 8.Pre-stroke modified Rankin Scale (mRS) score of 0-1; 9.Written informed consent provided by patient or legal representative;
Exclusion criteria
Exclusion criteria: 1.Contraindications or intolerance to glyceryl trinitrate (GTN), such as known allergy to GTN or organic nitrates, severe anemia (hemoglobin 3.0 on oral anticoagulant therapy; 5.Baseline blood glucose level 22.2 mmol/L; 6.Severe known renal impairment requiring dialysis (hemodialysis or peritoneal dialysis) or known creatinine clearance <60 mL/min; 7.Clinical history, previous imaging, or clinical judgment suggesting intracranial tumor, arteriovenous malformation (AVM), or intracranial arterial dissection; 8.Pregnancy or breastfeeding; 9.Presence of life-threatening illness within the previous 6 months preventing 3-month follow-up assessments, such as malignancy, heart failure, or other severe conditions; 10.Current participation in another clinical study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with functional independence (mRS score 0–2) 90 days after thrombectomy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of surviving ischemic penumbra;Infarct volume on 7 (±2) days after thrombectomy or at discharge (which occurs first);Comparison of other proportions of mRS 90 days after thrombectomy;Distribution of Barthel scores 90 days after the thrombectomy;Change of NIHSS score;Proportion of symptomatic intracranial hemorrhage 7 days after thrombectomy;Percentage of early neurological function improvement;Adverse events 90 days after thrombectomy;Distribution of mRS 90 days after thrombectomy;Proportion of intracranial hemorrhage 7 days after thrombectomy;Percentage of neurological function deterioration 7 days after thrombectomy;Infarct Expansion Ratio on 7 (±2) days after thrombectomy or at discharge (which occurs first);All-cause mortality 90 days after the thrombectomy; | — |
Countries
China
Contacts
Public ContactGengxiao Kun
Beijing Luhe Hospital, Capital Medical University
Outcome results
None listed