NCT03874702

Brief Summary

The use of the systems of machine learning for the quantification, location and diagnosis of ischemic stroke in non-contrasted head computed tomography, is a method with high efficacy, accessible and susceptible for standardization, for the assistance in the clinical decision making in the absence of specialized health personnel for the attention of this disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

August 15, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

5.8 years

First QC Date

March 12, 2019

Last Update Submit

May 17, 2021

Conditions

StrokeIschemic Stroke

Keywords

strokeartificial intelligenceischemic stroke

Outcome Measures

Primary Outcomes (1)

  • Alberta Stroke Program Early Computed Tomography Score

    The Alberta stroke programme early CT score (ASPECTS) 1 is a 10-point quantitative topographic CT scan score used in patients with middle cerebral artery stroke. It has also been adapted for the posterior circulation. Scoring system Segmental assessment of the MCA vascular territory is made and 1 point is deducted from the initial score of 10 for every region involved: caudate putamen internal capsule insular cortex M1: "anterior MCA cortex," corresponding to frontal operculum M2: "MCA cortex lateral to insular ribbon" corresponding to anterior temporal lobe M3: "posterior MCA cortex" corresponding to posterior temporal lobe M4: "anterior MCA territory immediately superior to M1" M5: "lateral MCA territory immediately superior to M2" M6: "posterior MCA territory immediately superior to M3"

    1 day

Study Arms (1)

Ischemic stroke patients with <4.5 hours of onset .

analysis of the computed tomography without contrast and detection of early changes, scoring with ASPECTS score and integration to the machine learning data base.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients with ischemic stroke diagnosis, within the \<4.5 hrs. window after the onset of the symptoms

You may qualify if:

  • Patients with ischemic stroke.
  • Patients with \<4.5 hours of symptom onset.

You may not qualify if:

  • Patients with hemorrhagic stroke diagnosis.
  • Patients with other cerebrovascular diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de neurociencias

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (11)

  • Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.

    PMID: 25520374BACKGROUND

  • Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

    PMID: 28122885BACKGROUND

  • Saver JL. Time is brain--quantified. Stroke. 2006 Jan;37(1):263-6. doi: 10.1161/01.STR.0000196957.55928.ab. Epub 2005 Dec 8.

    PMID: 16339467BACKGROUND

  • Grotta JC, Chiu D, Lu M, Patel S, Levine SR, Tilley BC, Brott TG, Haley EC Jr, Lyden PD, Kothari R, Frankel M, Lewandowski CA, Libman R, Kwiatkowski T, Broderick JP, Marler JR, Corrigan J, Huff S, Mitsias P, Talati S, Tanne D. Agreement and variability in the interpretation of early CT changes in stroke patients qualifying for intravenous rtPA therapy. Stroke. 1999 Aug;30(8):1528-33. doi: 10.1161/01.str.30.8.1528.

    PMID: 10436095BACKGROUND

  • Mullins ME, Lev MH, Schellingerhout D, Koroshetz WJ, Gonzalez RG. Influence of availability of clinical history on detection of early stroke using unenhanced CT and diffusion-weighted MR imaging. AJR Am J Roentgenol. 2002 Jul;179(1):223-8. doi: 10.2214/ajr.179.1.1790223.

    PMID: 12076941BACKGROUND

  • Nagel S, Wang X, Carcel C, Robinson T, Lindley RI, Chalmers J, Anderson CS; ENCHANTED Investigators. Clinical Utility of Electronic Alberta Stroke Program Early Computed Tomography Score Software in the ENCHANTED Trial Database. Stroke. 2018 Jun;49(6):1407-1411. doi: 10.1161/STROKEAHA.117.019863. Epub 2018 May 18.

    PMID: 29777016BACKGROUND

  • Jiang F, Jiang Y, Zhi H, Dong Y, Li H, Ma S, Wang Y, Dong Q, Shen H, Wang Y. Artificial intelligence in healthcare: past, present and future. Stroke Vasc Neurol. 2017 Jun 21;2(4):230-243. doi: 10.1136/svn-2017-000101. eCollection 2017 Dec.

    PMID: 29507784BACKGROUND

  • Somashekhar SP, Sepulveda MJ, Puglielli S, Norden AD, Shortliffe EH, Rohit Kumar C, Rauthan A, Arun Kumar N, Patil P, Rhee K, Ramya Y. Watson for Oncology and breast cancer treatment recommendations: agreement with an expert multidisciplinary tumor board. Ann Oncol. 2018 Feb 1;29(2):418-423. doi: 10.1093/annonc/mdx781.

    PMID: 29324970BACKGROUND

  • Cantu-Brito C, Ruiz-Sandoval JL, Murillo-Bonilla LM, Chiquete E, Leon-Jimenez C, Arauz A, Villarreal-Careaga J, Barinagarrementeria F, Ramos-Moreno A; PREMIER Investigators. The first Mexican multicenter register on ischaemic stroke (the PREMIER study): demographics, risk factors and outcome. Int J Stroke. 2011 Feb;6(1):93-4. doi: 10.1111/j.1747-4949.2010.00549.x. No abstract available.

    PMID: 21205252RESULT

  • Cantu-Brito C, Ruiz-Sandoval JL, Murillo-Bonilla LM, Chiquete E, Leon-Jimenez C, Arauz A, Villarreal-Careaga J, Rangel-Guerra R, Ramos-Moreno A, Barinagarrementeria F; PREMIER Investigators. Acute care and one-year outcome of Mexican patients with first-ever acute ischemic stroke: the PREMIER study. Rev Neurol. 2010 Dec 1;51(11):641-9. English, Spanish.

    PMID: 21108226RESULT

  • Lee EJ, Kim YH, Kim N, Kang DW. Deep into the Brain: Artificial Intelligence in Stroke Imaging. J Stroke. 2017 Sep;19(3):277-285. doi: 10.5853/jos.2017.02054. Epub 2017 Sep 29.

    PMID: 29037014RESULT

Related Links

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Rodrigo Ramos Zúñiga, M.D. Ph.D.

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

  • Eduardo Gerardo Mendizábal Ruiz, Ph.D.

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

  • José Luis Ruiz Sandoval, M.D.

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

  • Ivan Segura Duran, M.D.

    University of Guadalajara

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 14, 2019

Study Start

August 15, 2019

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)