Acute Ischemic Stroke Clinical Trial
— QUEST-KETAOfficial title:
Quelling of Excitotoxicity in Acute Stroke With Ketamine
The investigators plan to undertake a phase II study to investigate the efficacy and side effects of intravenous ketamine to reduce neuroexcitotoxicity, and thus provide neuroprotection in patients diagnosed with acute ischemic stroke.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. All patients who are 18 years or older, presenting or admitted to the study site with acute ischemic stroke, up to 24 hours since their last known well time 2. An MRI evidence of acute ischemic infarct on the diffusion-weighted imaging with ADC correlate 3. Pre-stroke modified Rankin scale of 0-2 4. Patient should be willing to participate in the study by providing a written consent himself/herself or through a proxy. Exclusion Criteria: 1. Eligibility to receive IV Alteplase or intra-arterial thrombectomy/embolectomy 2. Longer than 24 hours since last known well time 3. Pre-stroke modified Rankin scale of 3 or above. 4. Pregnant or lactating females 5. Pre-existing psychiatric illness 6. Intracranial hemorrhage of any type at presentation 7. Seizure at onset of symptoms 8. Sustained uncontrolled hypertension defined as Systolic Blood pressure greater than 185 mmHg or Diastolic Blood Pressure greater than 110 mmHg, despite administration of antihypertensive medications 9. Known hypersensitivity or adverse reaction to prior administration of Ketamine 10. Inability/refusal to provide consent by the patient or through a proxy |
Country | Name | City | State |
---|---|---|---|
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Lower Merion Neurology Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in weighted modified Rankin scale score between day 1 and 90 will be assessed. | An improvement of 2 in mRS score will be considered favorable outcome. | On day 1 and at 90 days | |
Secondary | Barthel's index | An improvement of 10 or more points in Barthel's index will be considered a favorable outcome. | On day 1, and at 90 days | |
Secondary | NIH stroke scale score | On day 1, day 4 or discharge whichever is earlier, and at 90 days | ||
Secondary | Depression score using the PHQ9 questionnaire | On day 1, and day 4 or discharge whichever is earlier. | ||
Secondary | Infarct volumes | Measured from the DWI-MRI and/or CT images | On day 1, and day 4 or discharge whichever is earlier | |
Secondary | All cause mortality | 90 days | ||
Secondary | Stroke-related mortality | 90 days | ||
Secondary | Symptomatic intracranial hemorrhage | Day 4 or discharge whichever is earlier | ||
Secondary | Deterioration in neurologic status | Increase of 4 or more points in the NIH stroke scale | Up to day 4 or discharge whichever is earlier |
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