Status:
COMPLETED
PROMISE (Somatosensory Evoked POtEntials MonItoring During Acute Ischemic StrokE) Study
Lead Sponsor:
Fundació Institut Germans Trias i Pujol
Collaborating Sponsors:
Fundació La Marató de TV3
Conditions:
Acute Cerebrovascular Accident
Endovascular Procedures
Eligibility:
All Genders
18+ years
Brief Summary
Endovascular treatment in patients with acute ischemic stroke due to large vessel occlusion does not always lead to good clinical and functional outcome, despite achieving complete arterial recanaliza...
Detailed Description
PROMISE (somatosensory evoked PotEntials MonItoring during the acute ischemic StrokE) is a prospective, observational, single center study of somatosensory evoked potentials (SEPs) monitoring with bli...
Eligibility Criteria
Inclusion
- Acute stroke with a demonstrated occlusion in the anterior circulation (M1 or M2 segment of middle cerebral artery with or without ipsilateral internal carotid artery (ICA)significant stenosis or occlusion diagnosed by CT angiography (CTA) or angio-MRI) undergoing urgent thrombectomy procedure.
- Prestroke functional independence of 2 or less on the modified Rankin scale (ranging from 0 \[no symptoms\] to 6 \[death\]),
- Baseline score of at least 6 points on the National Institutes of Health Stroke Scale (NIHSS), which ranges from 0 to 42, with higher values indicating more severe deficit.
Exclusion
- Evidence by imaging of a large ischemic core, as indicated by an Alberta Stroke Program Early Computed Tomography Score (ASPECTS) of less than 5 on computed tomography (CT) without the use of contrast material or a score of less than 4 on diffusion-weighted magnetic resonance imaging (MRI) (ASPECTS values range from 0 to 10, with higher values indicating less infarct burden). These cutoff values of the ischemic core have been selected in agreement with the treatment effect showed in the HERMES trial meta-analysis collaboration (Presented at the International Stroke Conference, Houston, 2017).
- Well-documented history of neuromuscular disorders, stroke or central nervous system tumors that could interfere in the SEPs assessment.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT04099615
Start Date
January 1 2018
End Date
April 30 2020
Last Update
November 8 2023
Active Locations (1)
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1
Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, Spain, 08916