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PLATO: Posterior cerebraL ArTery Occlusion Study

Sponsor
Boston Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05291637
Collaborator
Heidelberg University (Other)
500
Enrollment
27
Locations
15.8
Anticipated Duration (Months)
18.5
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

For this retrospective study, the investigators will collect and analyze data of patients who presented with posterior artery occlusion and underwent mechanical thrombectomy (the type of endovascular stroke treatment) and intravenous thrombolysis (the type of non-endovascular stroke treatment).

The electronic health records will be queried for the demographic, medical history, and outcomes data of all patients with posterior cerebral artery occlusion who underwent mechanical thrombectomy, intravenous thrombolysis (IVT), or medical management.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The primary aims of the research are to evaluate, in patients presenting with posterior artery occlusion (PCA), whether favorable outcome would be superior for EVT compared to

    Medically Management (MM), inclusive of intravenous thrombolysis (IVT), as measured by:

    • 90-day modified Rankin Scale (mRS) ordinal shift or

    • decrease in NIH Stroke Scale/Score (NIHSS) by two points at 24 hours or at hospital discharge

    The secondary aims are to evaluate in patients presenting with PCA occlusion, other outcome and safety metrics:

    • 90-day functional independence, mRS 0-2

    • 90-day excellent outcome, mRS 0-1

    • Visual field recovery (none, partial, complete) by 90-days

    • rate of reperfusion by modified thrombolysis in cerebral infarction (TICI) scale grade

    • any intracranial hemorrhage

    • symptomatic intracranial hemorrhage

    • mortality

    In subgroup analysis, the investigators aim to identify subgroups that may confer differential treatment benefit by:

    • location of occlusion on the PCA segment (P1, P2, P3)

    • NIHSS strata (0-6, 7-15,>16)

    • time from symptom onset to treatment (0 to <6h vs 6-24h)

    • posterior circulation (PC) Acute Stroke Prognosis Early Computed Tomography Score (ASPECTS)

    • visual field defect on presentation

    The investigators hypothesize that greater benefit in outcomes would be seen in EVT treated patients with higher NIHSS, more proximal PCA occlusion, higher PC ASPECTS scores, and shorter time from symptom onset to treatment.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Endovascular Therapy vs Medical Management of PosterIor Cerebral Artery Occlusion Stroke
    Actual Study Start Date :
    Jan 5, 2022
    Anticipated Primary Completion Date :
    May 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Medical management cohort

    Patients who have undergone medical management stroke treatment from 1/01/2003 to 01/01/2022; this could include intravenous thrombolysis.
    EVT management cohort

    Patients who have undergone EVT stroke treatment from 01/01/2015 to 01/01/2022

    Outcome Measures

    Primary Outcome Measures

    1. Change in stroke outcome based on modified Rankin Scale (mRS) [baseline, 90 days]

      The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. Scores can range from 0-6, where 0 is no disability, 5 is disability requiring constant care for all needs, and 6 is death. For this outcome an ordinal shift analysis will be done, assessing all changes across the range from baseline at 90 days.

    2. Change in NIH Stroke Score (NIHSS) [baseline, 7 days]

      The NIH Stroke Scale/Score (NIHSS) is is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Scores can range from 0 to 42 and higher scores are associated with more severe stroke: 1-4= Minor stroke, 5-15= Moderate stroke, 15-20= Moderate/severe stroke, and 21-42 =Severe stroke.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Had an ischemic stroke with isolated posterior cerebral artery occlusion (P1, P2, or P3 segments) and was medically managed or managed with EVT during the study time period.
    Exclusion Criteria:

    • Patient with documented basilar artery occlusion and concomitant PCA occlusion

    • Patient with documented basilar artery occlusion, migration with secondary PCA occlusion

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barrow Neurological Institute Phoenix Arizona United States 85013
    2 University of Miami Miami Florida United States 33124
    3 Miami Baptist Health Miami Florida United States 33176
    4 Emory University School of Medicine Atlanta Georgia United States 30322
    5 Iowa University Medical School Iowa City Iowa United States 52242
    6 Boston Medical Center Boston Massachusetts United States 02118
    7 Cooper University Healthcare Camden New Jersey United States 08103
    8 University of Buffalo Buffalo New York United States 14261
    9 Mount Sinai Health New York New York United States 10003
    10 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15261
    11 Valley Baptist Harlingen Texas United States 78550
    12 UT Texas Medical Center Houston Texas United States 77030
    13 Helsinki University Hospital Helsinki Finland 00290
    14 Hopital Pitie-Salpetriere Paris France
    15 Charite Berlin Berlin Germany
    16 Universitätsklinikum Knappschaftskrankenhaus Bochum Bochum Germany
    17 University Clinics Dresden Dresden Germany
    18 Universitätsklinikum Erlangen Erlangen Germany
    19 University Medical Center Hamburg-Eppendorf Hamburg Germany
    20 Heidelberg University Heidelberg Germany 69117
    21 IRCCS Istituto delle Scienze Neurologiche di Bologna Bologna Italy 47521
    22 MR CLEAN Registry Amsterdam Netherlands
    23 Egas Moniz Hospital Lisboa Portugal 1349-019
    24 Centro Hospitalar Universitário de Lisboa Central Lisbon Portugal
    25 Vall D'Hebron Barcelona Spain
    26 Lausanne University Hospital Lausanne Vaud Switzerland 1011
    27 University Hospital Basel Basel Switzerland

    Sponsors and Collaborators

    • Boston Medical Center
    • Heidelberg University

    Investigators

    • Principal Investigator: Thanh N Nguyen, MD, Boston Medical Center, Neurology
    • Principal Investigator: Simon Nagel, MD, Heidelberg University Hospital, Neurology

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boston Medical Center
    ClinicalTrials.gov Identifier:
    NCT05291637
    Other Study ID Numbers:
    • H-40712
    First Posted:
    Mar 22, 2022
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Boston Medical Center
    Posterior occlusion artery (PCA)
    Intravenous thrombolysis (IVT)
    Endovascular therapy (EVT)
    Modified Rankin Scale (mRS)
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke

    Study Results

    No Results Posted as of Apr 6, 2022