Mechanical Thrombectomy in Acute Ischemic Stroke Beyond the Time of Window: Non Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 57
- Locations
- 3
- Primary Endpoint
- 2- Measuring the changes in NIHSS on day 90
Study Overview
Brief Summary
Background: intravenous alteplase appears to be much less effective at opening proximal occlusions of the major intracranial arteries, which account for more than one third of cases of acute anterior-circulation stroke and expanding time window using mechanical thrombectomy can improve clinical outcome in patients that would have only received conservative treatment.
The aim of this work is to evaluate the effectiveness of endovascular therapy within 24 hours of symptom onset and to compare clinical outcome of endovascular therapy with the standard medical therapy at the end of 3rd month follow up.
Material and Methods 57 subjects presenting with an acute ischemic stroke caused by occlusion of the proximal middle cerebral artery (M1 segment) or Internal carotid artery ( ICA segment) within 24 hours from symptom onset as documented by Ct, and or MRI perfusion were recruited consecutively from 2 University hospitals Ain shams University Hospital (32 Patients) and Aswan University (25 patients). Assessment of each subject was performed using NIHSS, and MRS, Aspect score, before intervention. Follow up was done using the same clinical scale one week and the 3 month after the onset.
Primary outcome NIHSS and MRS at the end of 3 month after the onset. secondary outcome complications (cerebral Hge) and death at 3 months.
Detailed Description
Background Expanding time window using the emerging technologies for mechanical thrombectomy can improve chances of achieving successful thrombectomy and improve clinical outcome in patients that would have only received conservative treatment. The aim of this work is to evaluate the effectiveness and safety of endovascular therapy within 24 hours of symptom onset and to compare clinical outcome of endovascular therapy and standard medical therapy at the end of 3rd month.
Subjects and Methods:
This is a multicenteric case-control clinical trial (Ain shams and Aswan university hospitals), comparing clinical improvement and mortality/morbidity in patients presenting with acute ischemic stroke stroke caused by occlusion of the proximal middle cerebral artery (M1 segment) or Internal carotid artery (distal ICA segment) within 24 hours from symptom onset.
Onset of stroke was defined as time they were last known to be well. Ischemic stroke is characterized by the sudden loss of blood circulation to an area of the brain, resulting in a corresponding loss of neurologic function. It included 57 patients with acute ischemic stroke due to large vessel occlusion (LVO) admitted either to neurology department of Ain shams university hospitals or Aswan university hospitals between during the period from Jan 2019 and August 2019
All patients were subjected to the following:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
2- Measuring the changes in NIHSS on day 90
Time Frame: 3 months
2- Changes in National Institute of Health Stroke Scale (NIHSS) were also measured at baseline (pre-thrombectomy) and on day 90. Favorable outcome when the score decrease by 4 or more point of the score.
1- Measuring the Modified Rankin Score (MRS) on day 90
Time Frame: 3 months
1- Measuring the Modified Rankin Score (MRS) on day 90 (ranging from, 0 to 6, with higher scores indicating greater disability). Favorable outcome was defined as achieving functional independence (mRS of 0,1or 2) poor outcome was defined as MRS of 3-5.
Secondary Outcomes
- 1-Estimate the number and percent of participants who have vascular recanalization(3 months)
- 2- Estimate the number of participants who developed complications(3 months)
Investigators
Eman M. Khedr
Professor of Neurology
Assiut University