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General Versus Regional Anesthesia for Carotid Endarterectomy at Acute Ischemic Stroke Trial

Study acronym: GRACE AIST
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study title shortened, about 3 wordsv5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 1, 2024 to Jul 1, 2024
    v3
  4. Start date: Feb 1, 2024 to Apr 1, 2024v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study is planned to evaluate the effectiveness and safety of two types of anesthesia (regional and general) for carotid endarterectomy in 100 patients with acute stage of stroke: 50 patients will be operated under regional anesthesia and the remaining 50 patients under general anesthesia. Patient inclusion criteria: 1. Ischemic stroke in the middle cerebral artery territory 2. Ipsilateral stenosis of the internal carotid artery more than 50% 3. Neurological deficit at the time of surgical treatment: the modified Rankin scale (mRs) score of 0-4 and the US National Institutes of Health (NIHSS) stroke scale score no more than 12 4. The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply 5. Terms of operation: from 1 to 28 days from the moment of ischemic stroke The primary intra-hospital and/or 30-day study endpoints: 1. Perioperative ipsilateral ischemic stroke. 2. Any stroke: contralateral ischemic or any hemorrhagic stroke. 3. Myocardial infarction. 4. Hemorrhagic complications that required surgical revision of the operating wound or transfusion of blood components. 5. Surgical site infection 6. Death 7. Main adverse cardiovascular events (stroke + myocardial infarction + death).
Trial Details
NCT Number NCT06175715
Lead Sponsor Pirogov Russian National Research Medical University
Conditions
(from sponsor)		 Acute Ischemic Stroke
Related terms Ischemic Stroke
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov