Emergency Stroke Unit With NeuAngio-CT (ESU-ACT)

Official title

Effect of Emergency Stroke Unit With NeuAngio-CT Direct for Acute Ischemic Stroke and Suspected Intracranial Large Vessel Occlusion (ESU-ACT)

Overview

Rationale: Acute ischemic stroke caused by large-vessel occlusion (LVO) requires rapid recanalization to minimize neurological damage, as shorter onset-to-reperfusion times are strongly associated with better clinical outcomes. Conventional management workflows, which involve separate non-contrast CT or multimodal imaging assessments prior to transfer to the angiography suite, often introduce significant delays. The implementation of a "one-stop" management model using a hybrid sliding-gantry CT/DSA suite allows for immediate diagnosis and subsequent intervention in a single clinical environment, potentially streamlining the transition to treatment. Therefore, the aim of this study is to demonstrate the superiority of the one-stop hybrid suite workflow compared to standard imaging-first management in improving functional outcomes for patients with suspected LVO presenting within 6 hours of symptom onset. Methods and Design: This study is a prospective, multicenter, matched cluster, open-label, blinded endpoint non-randomized cohort. It includes patients aged ≥18 years with a RACE score ≥4, a pre-stroke mRS score ≤1, and suspected intracranial LVO within 6 hours of onset. Hospitals in the exposure group utilize an Emergency Stroke Unit equipped with a sliding NeuAngio-CT/DSA hybrid suite, while control hospitals follow the conventional imaging workflow. Study Outcomes: The primary outcome is the proportion of patients achieving functional independence at 90 days, defined as a modified Rankin Scale (mRS) score of 0-2. The primary safety outcome is the proportion of patients with all-cause mortality at 7 days or at the time of hospital discharge.

Detailed description

This study employs a multicenter, matched-cluster controlled design wherein 5 to 10 hospitals equipped with Neusoft Medical's domestic sliding-gantry Angio-CT/Digital Subtraction Angiography (ACT/DSA) system, and staffed by personnel who have completed standardized operational training, will be selected as the Exposure Group, while a corresponding 5 to 10 matched hospitals lacking this integrated system will serve as the Control Group. In the Exposure Group, the protocol dictates an optimized direct-to-angiography suite workflow; upon arrival, patients undergo immediate neurological evaluation utilizing the Rapid Arterial oCclusion Evaluation (RACE) scale and stat laboratory testing before being transferred directly to the angio suite. Intra-suite imaging is then acquired via the sliding-gantry system to perform non-contrast computed tomography (NCCT) and CT angiography (CTA). If a large vessel occlusion (LVO) is confirmed-specifically involving the M1/M2, P1, A1, or basilar artery (BA) segments-endovascular therapy (EVT), encompassing mechanical thrombectomy, balloon angioplasty, and/or stenting, is initiated immediately on the same table. For patients without an identified LVO, intravenous thrombolysis (IVT) is administered in situ if clinical eligibility is met. Conversely, patients in the Control Group will adhere to standard-of-care diagnostic pathways, undergoing initial cross-sectional neuroimaging (NCCT/CTA or MRI/MRA) in a conventional Radiology Department, where IVT is administered in accordance with current guidelines; if an LVO is radiologically confirmed during this standard workflow, patients are subsequently transferred to a separate angiography suite to undergo EVT.

Primary outcome measures

• Proportion of patients with mRS score 0-2 at 90 days [Time frame: at 90 days]

Secondary outcome measures (12)

• Proportion of patients with mRS score 0-3 at 90 days [Time frame: at 90 days]
• Ordinal (shift) analysis of mRS at 90 days [Time frame: at 90 days]
• Length of hospital stay [Time frame: From date of enrollment until the date of discharge, assessed up to 3 months]
• Hospitalization cost [Time frame: From date of enrollment until the date of discharge, assessed up to 3 months]
• Incidence of neurological deterioration within 24 hours after enrollment [Time frame: within 24 hours after enrollment]
• Incidence of neurological deterioration at 7 days/discharge; [Time frame: at 7 days/discharge]
• Proportion of patients with "early efficacy (NIHSS score decrease ≥10 points, or NIHSS score 0-1)" at 7 days of hospitalization/discharge [Time frame: at 7 days or at discharge]
• Change in infarct volume at 24 hours (±3 hours) (median difference), assessed by central laboratory using MR T2/Flair or CT (evaluated in patients who received endovascular therapy) [Time frame: at 24 hours (±3 hours)]
• Proportion of patients with mTICI > 2b (evaluated in patients who received endovascular therapy) [Time frame: immediately after the intervention]
• Median DPT time measurement (door-to-arterial puncture time) (evaluated in patients who received endovascular therapy) [Time frame: door-to-arterial puncture time，recorded immediately after the intervention]
• Median DRT time measurement (door-to-reperfusion time) (evaluated in patients who received endovascular therapy) [Time frame: door-to-reperfusion time，recorded immediately after the intervention]
• Median DNT time measurement (door-to-needle time) (evaluated in patients who received IVT) [Time frame: door-to-needle time，recorded immediately after the intervention]

Eligibility criteria

• Inclusion Criteria:

• Age ≥ 18 years;
• Clinically diagnosed with acute ischemic stroke;
• RACE score ≥ 4 points upon hospital arrival;
• Time from symptom onset/last known normal to hospital arrival ≤ 6 hours;
• Pre-stroke mRS score 0-1;
• Informed consent signed by the patient or their legal representative.
• Exclusion Criteria:

• Hemorrhagic stroke diagnosed by cranial CT or MRI during this current episode;
• Uncontrolled hypertension with medication (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg) (Note: Patients may be included if blood pressure can be successfully reduced and maintained at an acceptable level with medication);
• Known hereditary or acquired bleeding tendency, such as coagulation factor deficiency, or INR > 3.0 or PT > 3 times the normal range after anticoagulant therapy (Patients without a history of coagulation dysfunction or suspected coagulation dysfunction do not need to wait for laboratory results of INR or prothrombin time before enrollment);
• Received heparin, low-molecular-weight heparin (e.g., dalteparin sodium), or thrombin inhibitors (e.g., bivalirudin, argatroban) within 24 hours with a history of coagulation disorders;
• Baseline laboratory values: blood glucose < 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L), hemoglobin count < 7 mmol/l (11.28 g/dl); platelet count < 50,000/μl;
• Patients with renal failure, defined as serum creatinine > 3.0 mg/dl (264 μmol/l) (Note: Patients undergoing dialysis can be included regardless of serum creatinine level);
• Cerebral embolism caused by septic emboli or bacterial endocarditis;
• History of stroke within the past 3 months;
• Seizure at stroke onset leading to diagnostic confusion and difficulty in accurate baseline RACE assessment;
• History of previous neuropsychiatric disorders that make accurate neurological function assessment difficult, such as dementia patients taking cholinesterase inhibitors;
• Diagnosis of cerebral vasculitis, brain tumor, or traumatic brain injury within the past 3 months;
• Major organ surgery or biopsy within 30 days;
• Active bleeding or recent bleeding within 30 days;
• History of previous intracranial stent implantation;
• History of severe contrast agent allergy (non-rash allergy);
• Patients with other contraindications to reperfusion therapy or who refuse reperfusion therapy;
• Life expectancy less than 180 days;
• Lactating women or women with positive pregnancy test on admission;
• Patients who refuse or cannot cooperate with follow-up.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT07456228 · KY2025-215-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗