New York City Mobile Interventional Stroke Team

Completed

• Conditions: Acute Stroke
• Interventions: Other: Acute Endovascular Stroke Treatment

• Registration Number: NCT03048292
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Endovascular treatment has recently become the recommended therapy for acute stroke after the publication of five randomized trials (MR CLEAN1, ESCAPE2, EXTEND IA3, SWIFT PRIME4, REVASCAT5) in 2015 that demonstrate its efficacy. Hospitals need to adapt to these updated stroke care guidelines, and many hospitals are not appropriately equipped for neurointerventional procedures. Decreased time to treatment is associated with favorable clinical outcomes, and best practices to optimize workflow between comprehensive stroke centers and secondary hospitals have become an important area of study. This prospective study is being conducted on acute stroke cases within the Mount Sinai Health System from 1 June 2016 up until 31 December 2018. The researchers would like to evaluate how variable methods of interventional service delivery for acute stroke affect clinical measures and outcomes.

More specifically, the researchers are conducting this study in order to determine whether outcomes of neurointervention for large vessel occlusion in stroke, for patients presenting to and receiving treatment at a comprehensive stroke center, will be superior to that delivered by a mobilized intervention team at a central satellite hospital. In particular, the hypothesis is that factors affecting outcome include presentation to secondary hospital, delays with transfer including traffic conditions and time of day, and the acquisition of complex imaging within secondary hospitals.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Primary Completion: 2019-07-16
• Study Completion: 2019-07-16
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Core Comprehensive Stroke Center Treatment	Acute Endovascular Stroke Treatment	-
Mobilized Neurointervention Team	Acute Endovascular Stroke Treatment	Patients undergoing endovascular stroke interventions.
Mobilized Patient	Acute Endovascular Stroke Treatment	-

Primary Outcome Measures

Name	Time	Method
Treatment times	90 days	Time between first hospital arrival and final recanalization

Secondary Outcome Measures

Name	Time	Method
Time to groin puncture procedure	3 months	Time of first hospital arrival to groin puncture
NIHSS	90 days	National Institutes of Health Stroke Scale (NIHSS) a 11-item impairment scale to evaluate neurologic outcome and degree of recovery.; Each item is scored between 0 and up to 4, (0 normal function with higher score indicating higher level of impairment. with minimum score 0 and maximum possible score 42.
Time of EMS contact to groin puncture	90 days
modified Rankin Scale (mRS)	90 days	the mRS measures degree of disability/dependence after a stroke. the mRS is a scale that runs from 0 (no symptoms) to 6 (death).

Trial Locations

Locations (4)

Mount Sinai St Luke's; 🇺🇸 New York, New York, United States

Mount Sinai Health System; 🇺🇸 New York, New York, United States

Mount Sinai West; 🇺🇸 New York, New York, United States

Mount Sinai Beth Israel; 🇺🇸 New York, New York, United States