New York City Mobile Interventional Stroke Team (NYC MIST)
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
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
New York
-
New York, New York, Verenigde Staten, 10019
- Mount Sinai West
-
New York, New York, Verenigde Staten, 10029
- Mount Sinai Health System
-
New York, New York, Verenigde Staten, 10025
- Mount Sinai St Luke's
-
New York, New York, Verenigde Staten, 10003
- Mount Sinai Beth Israel
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Mobilized Neurointervention Team
Patients undergoing endovascular stroke interventions.
|
Andere namen:
|
|
Mobilized Patient
|
Andere namen:
|
|
Core Comprehensive Stroke Center Treatment
|
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Treatment times
Tijdsspanne: 90 days
|
Time between first hospital arrival and final recanalization
|
90 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to groin puncture procedure
Tijdsspanne: 3 months
|
Time of first hospital arrival to groin puncture
|
3 months
|
|
Time of EMS contact to groin puncture
Tijdsspanne: 90 days
|
90 days
|
|
|
NIHSS
Tijdsspanne: 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. |
90 days
|
|
modified Rankin Scale (mRS)
Tijdsspanne: 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).
|
90 days
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Johanna Fifi, MD, Icahn School of Medicine at Mount Sinai
Publicaties en nuttige links
Algemene publicaties
- Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama a Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17. Erratum In: N Engl J Med. 2015 Jan 22;372(4):394.
- Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.
- Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11.
- Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ, Wu TY, Brooks M, Simpson MA, Miteff F, Levi CR, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Priglinger M, Ang T, Scroop R, Barber PA, McGuinness B, Wijeratne T, Phan TG, Chong W, Chandra RV, Bladin CF, Badve M, Rice H, de Villiers L, Ma H, Desmond PM, Donnan GA, Davis SM; EXTEND-IA Investigators. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015 Mar 12;372(11):1009-18. doi: 10.1056/NEJMoa1414792. Epub 2015 Feb 11.
- Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Baxter BW, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Singer OC, Jahan R; SWIFT PRIME Investigators. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015 Jun 11;372(24):2285-95. doi: 10.1056/NEJMoa1415061. Epub 2015 Apr 17.
- Morey JR, Zhang X, Marayati NF, Matsoukas S, Fiano E, Oxley T, Dangayach N, Stein LK, Fara MG, Skliut M, Kellner C, De Leacy R, Mocco J, Tuhrim S, Fifi JT. Mobile Interventional Stroke Teams Improve Outcomes in the Early Time Window for Large Vessel Occlusion Stroke. Stroke. 2021 Aug;52(9):e527-e530. doi: 10.1161/STROKEAHA.121.034222. Epub 2021 Aug 5.
- Morey JR, Oxley TJ, Wei D, Kellner CP, Dangayach NS, Stein L, Hom D, Wheelwright D, Rubenstein L, Skliut M, Shoirah H, De Leacy RA, Singh IP, Zhang X, Persaud S, Tuhrim S, Dhamoon M, Bederson J, Mocco J, Fifi JT; Mount Sinai Stroke Investigators*. Mobile Interventional Stroke Team Model Improves Early Outcomes in Large Vessel Occlusion Stroke: The NYC MIST Trial. Stroke. 2020 Dec;51(12):3495-3503. doi: 10.1161/STROKEAHA.120.030248. Epub 2020 Nov 2.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GCO 16-1290
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .