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Completed

NCT Number: NCT03048292

New York City Mobile Interventional Stroke Team

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai Beth Israel, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients who consent to the study and present with acute stroke treated with thrombectomy in the Mount Sinai Health System (Mount Sinai, Mount Sinai West, Mount Sinai Beth Israel, Mount Sinai St. Luke's) from 1 June 2016 - 31 December 2018.

Exclusion criteria

  • If the patient is pregnant
  • Under age 18
  • A prisoner. If timing of treatment cannot be captured, patients with these data points will be excluded.

Treatment and study plan

Acute Endovascular Stroke Treatment

Other

Other names: Solitaire, Trevo, Embotrap, Medtronic, Stryker, Neuravi, Penumbra, Microvention

Primary outcomes

  1. Treatment times

    Time frame: 90 days

    Time between first hospital arrival and final recanalization

Secondary outcomes

  1. Time to groin puncture procedure

    Time frame: 3 months

    Time of first hospital arrival to groin puncture

  2. Time of EMS contact to groin puncture

    Time frame: 90 days

  3. NIHSS

    Time frame: 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.

  4. modified Rankin Scale (mRS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Reducing Disparities in Mechanical Embolectomy Access for Patients of New York City Via a Mobile Interventional Stroke Team: Systems of Care and Time-To-Treatment

Acronym: NYC MIST

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 9, 2017
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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