NCT06778226CompletedNot Applicable
ThRombectomy In Mild Ischemic Stroke With a Visible Intracranial veSsel Occlusion
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 4,827
- Locations
- 3
- Primary Endpoint
- Modified Rankin Scale
Study Overview
Brief Summary
The purpose of TRIMIS is to study how a medical procedure by the name of endovascular therapy compares to medical treatment alone in patients with mild stroke and a blood vessel occlusion in the brain
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acute ischemic stroke in an adult patient (18 years of age or older).
- •Onset (Last Seen Normal) time to treatment time <24 hours or unknown Last Seen Normal in whom Endovascular Therapy could be considered per local radiographic guidelines.
- •Mild stroke defined as an NIH Stroke Scale ≤ 5 at the time of treatment decision.
- •a. Patients with NIH Stroke Scale=0 can be included in the study if they have relevant abnormalities on neurological exam.
- •An acute intracranial vessel occlusion (Intracranial Internal Carotid Artery terminus (T or L clot), Middle Cerebral Artery (M1, M2, M3/beyond), Anterior Cerebral Artery (A1, A2, A3), V4, Basilar, Posterior Cerebral Artery) defined by non-invasive acute imaging (Computed Tomography, angiography (Computed Tomography Angiography) or Magnetic Resonance angiography (MRA)) that is neurologically relevant to the presenting symptoms and signs.
Exclusion Criteria
- •Stroke symptoms due to another non-ischemic acute neurological condition such as seizure with Post-ictal Todd's paralysis or focal neurological signs due to severe hypo- or hyperglycemia.
- •Hyperdensity on Non-contrast Computed Tomography consistent with intracranial hemorrhage. Any clinical suspicion of any intracranial hemorrhage even in the absence of visible blood on baseline brain imaging.
- •Large acute stroke >1/3 Middle Cerebral Artery territory or Alberta Stroke Programme Early CT score (ASPECTS<6 or established frank hypodensity relevant to the presenting acute stroke already visible on baseline CT scan.
- •Findings on acute CT or MRI to suggest that the
- •Patient has a severe or fatal or disabling illness that will impact decision regarding acute reperfusion therapies.
- •Clinical history, past imaging and clinical judgment suggest that the intracranial occlusion is chronic.
- •Stroke occurred as an inpatient.
- •Inclusion into any randomized control trials.
Arms & Interventions
Delayed Endovascular Therapy
Data previously collected from medical records of participants will be analyzed with the purpose of studying the efficiency of Delayed Endovascular Therapy. Length of the cohort is 6 years.
Medical Management
Data previously collected from medical records of participants will be analyzed with the purpose of studying the efficiency of Medical Management. Length of the cohort is 6 years.
Immediate Endovascular Therapy
Data previously collected from medical records will be analyzed with the purpose of studying the efficiency of Immediate Endovascular Therapy. Length of the cohort is 6 years.
Outcomes
Primary Outcomes
Modified Rankin Scale
Time Frame: 90 Days
Scores range from 0-6. (0 = normal, 6 = dead).
Secondary Outcomes
- Symptomatic Intracerebral Hemorrhage (sICH)(48 hours)
- Change in National Institute of Health Stroke Scale (NIHSS)(24 hours, 7 days)
- Modified Rankin Scale(7 days)
Investigators
Negar Asdaghi
Associate Professor of Neurology
University of Miami
Study Sites (3)
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