NCT07456228Toborzás még nem indult
Emergency Stroke Unit With NeuAngio-CT (ESU-ACT)
Effect of Emergency Stroke Unit With NeuAngio-CT Direct for Acute Ischemic Stroke and Suspected Intracranial Large Vessel Occlusion (ESU-ACT)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 6.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 500 (tervezett)
- Első benyújtás
- 2026. febr. 11.
- Kezdés
- 2026. márc.
- Elsődleges befejezés
- 2028. márc.
- Fő szponzor
- Beijing Tiantan Hospital
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT07456228
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 500
- 2026. márc. és az elsődleges befejezés (2028. márc.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
A regiszterben nem jelölt feltételek
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.