NCT07840794Toborzás még nem indult
Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Stimulation-Temperature-Oxygen-Positioning (STOP) Multimodal Neuroprotective Strategy for Acute Ischemic Stroke Undergoing Reperfusion Therapy: A Multicenter Randomized Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 27.
Rövid összefoglaló (regiszter, angolul)
Acute ischemic stroke may result in substantial disability despite timely reperfusion therapy because ischemic and reperfusion-related brain injury can continue before, during, and after restoration of blood flow. This investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate whether a protocolized Stimulation-Temperature-Oxygen-Positioning (STOP) multimodal neuroprotective strategy added to guideline-based reperfusion therapy and stroke-unit care improves 90-day functional outcome compared with standard care alone. A total of 380 adults with acute ischemic stroke treated with intravenous thrombolysis and/or endovascular therapy within 24 hours of symptom onset or last known well will be randomized in a 1:1 ratio to the STOP strategy plus standard care or standard care alone. The STOP strategy comprises transcutaneous auricular vagus nerve stimulation, protocolized normothermia targeting a body temperature of 37.5 °C or lower, high-flow normobaric oxygen, and dynamic head positioning according to reperfusion treatment and recanalization status. The primary outcome is the ordinal distribution of modified Rankin Scale scores at 90 days after randomization. Blinded assessors will evaluate functional outcomes, and a blinded central imaging core laboratory will adjudicate imaging outcomes. Among participants with anterior-circulation large-vessel occlusion who undergo endovascular treatment and achieve successful reperfusion (final mTICI grade 2b-3), eligible and consenting participants may enter an embedded randomized substudy comparing selective intra-arterial hypothermia with no additional intra-arterial infusion. The second randomization will occur only after successful reperfusion has been confirmed.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 380 (tervezett)
- Első benyújtás
- 2026. aug. 23.
- Kezdés
- 2026. nov. 1.
- Elsődleges befejezés
- 2028. aug. 31.
- Fő szponzor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT07840794
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 380
- 2026. nov. 1. és az elsődleges befejezés (2028. aug. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Established cerebral herniation, progressive severe cerebral edema, or an immediate requirement for decompressive surgery before enrollment.
Más betegség
- Intracranial hemorrhage on baseline imaging.
- Severe hypoxemia, severe respiratory failure, or another clinical condition requiring continuous high-concentration oxygen therapy or specialized respiratory support that prevents implementation of the assigned oxygen protocol. Endotracheal intubation or mechanical ventilation alone is not an exclusion criterion.
- Active persistent vomiting, inability to adequately protect the airway, severe respiratory distress, or another condition that makes protocolized 0° supine positioning unsafe.
- Clinically significant bradycardia, atrioventricular block, severe arrhythmia, or another condition considered by the investigator to make transcutaneous auricular vagus nerve stimulation inappropriate.
- Severe skin injury, infection, or another local condition at the auricular stimulation site that prevents transcutaneous auricular vagus nerve stimulation.
- Severe systemic infection, sepsis, or another serious acute illness likely to substantially affect short-term prognosis.
- Severe progressive or terminal disease with expected survival of less than 3 months.
- Any other condition that, in the investigator's judgment, makes trial participation inappropriate.
Egyéb
- Severe hypotension, shock, or other clinically significant hemodynamic instability.
- Pregnancy or breastfeeding.
- Current participation in another interventional clinical trial that may affect the assigned intervention or assessment of the primary outcome.
Kiket keres a vizsgálat
- Age 18 years or older.
- Clinical diagnosis of acute ischemic stroke.
- Baseline National Institutes of Health Stroke Scale score of 5 to 25.
- CTA, MRA, or DSA confirmation of an intracranial culprit arterial occlusion consistent with the presenting neurological deficit.
- Eligible for guideline-recommended reperfusion therapy and planned to receive, or already initiated, intravenous thrombolysis and/or endovascular therapy.
- Time from symptom onset or last known well to initiation of reperfusion therapy of 24 hours or less.
- Pre-stroke modified Rankin Scale score of 0 or 1.
- Written informed consent provided by the participant or an appropriate legally authorized representative.
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