Acute StrokeNYC MISTNCT03048292

New York City Mobile Interventional Stroke Team

An observational study of Acute Stroke, run by Icahn School of Medicine at Mount Sinai at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Stroke
What is being tested?: Acute Endovascular Stroke Treatment
How many people: 191 participants
Where: 4 sitesUnited States
Study dates: Jun 2016to 16 Jul 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients who consent to the study and present with acute stroke treated with thrombectomy in the Mount Sinai Health System.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Mount Sinai Beth Israel
New York, New York, 10003
Mount Sinai West
New York, New York, 10019
Mount Sinai St Luke's
New York, New York, 10025
Mount Sinai Health System
New York, New York, 10029

Other trials in United States

About this study

Official 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

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.

Conditions: Acute Stroke
Being tested: Acute Endovascular Stroke Treatment
Keywords: Embolectomy, Embolus, Thrombectomy, Thrombolysis, Thrombus, Mobile, Interventional, Neurointervention, Stroke, Ischemic, Acute, Endovascular, Cerebrovascular, Clot, Stent Retriever, Tissue Plasminogen Activator, Drip and Ship, Mothership, Trip and Treat
Medical subject headings: Stroke, Embolism, Thrombosis, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acute Endovascular Stroke TreatmentOther
Also called Solitaire, Trevo, Embotrap, Medtronic

Study groups in NCT03048292
Study group	Role	What they receive
Mobilized Neurointervention Team		Patients undergoing endovascular stroke interventions. Receives: Other: Acute Endovascular Stroke Treatment
Mobilized Patient		Not described Receives: Other: Acute Endovascular Stroke Treatment
Core Comprehensive Stroke Center Treatment		Not described Receives: Other: Acute Endovascular Stroke Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment times
Time between first hospital arrival and final recanalization
Measured: 90 days

Secondary outcomes (4)

Time to groin puncture procedure
Time of first hospital arrival to groin puncture
Measured: 3 months
Time of EMS contact to groin puncture
Measured: 90 days
NIHSS
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.
Measured: 90 days
modified Rankin Scale (mRS)
the mRS measures degree of disability/dependence after a stroke. the mRS is a scale that runs from 0 (no symptoms) to 6 (death).
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201616 Jul 2019

First posted9 Feb 2017 (estimated)
Study startJun 2016
Primary completion16 Jul 2019
Study completion16 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Acute StrokeStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03048292
Sponsor's protocol ID: GCO 16-1290
Acronym: NYC MIST
Status last verified: Jan 2020
First submitted: 7 Feb 2017
Last updated: 18 Jan 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 25517348
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.
PubMed 25671798
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.
PubMed 25671797
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.
PubMed 25882376
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.
PubMed 25882510
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.
PubMed 34348472
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.
PubMed 33131426

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
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INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
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All Acute Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT03048292
Acronym / sponsor ID: NYC MIST / GCO 16-1290
Conditions: Acute Stroke
Keywords: Embolectomy, Embolus, Thrombectomy, Thrombolysis, Thrombus, Mobile, Interventional, Neurointervention
Study type: Observational
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Study start: Jun 2016
Primary completion: 16 Jul 2019 (actual)
Study completion: 16 Jul 2019 (actual)
First posted: 9 Feb 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Mobilized Neurointervention Team	–	Other: Acute Endovascular Stroke TreatmentPatients undergoing endovascular stroke interventions.
Mobilized Patient	–	Other: Acute Endovascular Stroke Treatment
Core Comprehensive Stroke Center Treatment	–	Other: Acute Endovascular Stroke Treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who consent to the study and present with acute stroke treated with thrombectomy in the Mount Sinai Health System.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acute Endovascular Stroke TreatmentAlso: Solitaire, Trevo, Embotrap, Medtronic	Other	Core Comprehensive Stroke Center Treatment, Mobilized Neurointervention Team, Mobilized Patient

Primary outcome

Treatment times
Time frame: 90 days
Time between first hospital arrival and final recanalization

4 secondary outcomes

Time to groin puncture procedure
Time frame: 3 months
Time of EMS contact to groin puncture
Time frame: 90 days
NIHSS
Time frame: 90 days
modified Rankin Scale (mRS)
Time frame: 90 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
Background: PubMed 25517348Berkhemer 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.
Background: PubMed 25671798Goyal 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.
Background: PubMed 25671797Campbell 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.
Background: PubMed 25882376Saver 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.
Background: PubMed 25882510Jovin 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.
Derived from this study: PubMed 34348472Morey 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.
Derived from this study: PubMed 33131426Morey 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.
Individual participant dataSharing planned: No

Related trials for Acute Stroke

Recruiting
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Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
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A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
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Not yet recruitingPhase 4
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Not yet recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Johanna Fifi, MD principal investigator

Icahn School of Medicine at Mount Sinai

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Stroke, run by Icahn School of Medicine at Mount Sinai at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment times (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03048292, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.