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ERILs Und SNILs Unter SOC

Primary Purpose

Stroke, Acute

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
diffusion-weighted magnetic resonance imaging
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke, Acute

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: LAA stroke or TIA ERILs or SNILs detected in initialDW-MRI signed informed consent Exclusion Criteria: planned surgical intervention iv Thrombolysis atrial fibrillation contra indications against DW-MRI

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    magnetic resonance imaging

    Arm Description

    DW-MRI after ischemic stroke

    Outcomes

    Primary Outcome Measures

    1. How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment?
    DW-MRI to detect lesions

    Secondary Outcome Measures

    2. How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment and how many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days?
    DW-MRI to detect lesions

    Full Information

    First Posted
    March 14, 2023
    Last Updated
    March 14, 2023
    Sponsor
    Medical University of Vienna
    Collaborators
    Medical University Innsbruck
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05786170
    Brief Title
    ERILs Und SNILs Unter SOC
    Official Title
    Early Recurrent Ischemic Lesions (ERILs) and Silent Neurologic Ischemic Lesions (SNILs) in Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) - a Pilot- Observational Study Under Standard of Care (SOC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    lack of research funding
    Study Start Date
    September 2019 (Anticipated)
    Primary Completion Date
    July 5, 2021 (Actual)
    Study Completion Date
    July 5, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna
    Collaborators
    Medical University Innsbruck

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment? How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment? How many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days? Are there relevant risk faktors for the occurence of ERILs and SNILs (eg Diabetes or Biomarkers)?
    Detailed Description
    In this trial, patients will be observed if they develop early recurrent ischemic lesions (= ERILs) or silent neurologic ischemic lesions (= SNILs) after acute stroke or transitoric ischemic attack (TIA) based on atherothrombosis (LAA-stroke) on standard therapy during 30 days (day 7 and day 30 after acute event) via DW-MRI (diffusion-weighted magnetic resonance imaging). We want to investigate if diffusion-weighted imaging of silent brain infarcts occuring during standard therapy is a suitable surrogate outcome measure for interventional studies

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Acute

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    magnetic resonance imaging
    Arm Type
    Experimental
    Arm Description
    DW-MRI after ischemic stroke
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    diffusion-weighted magnetic resonance imaging
    Intervention Description
    diffusion-weighted magnetic resonance imaging
    Primary Outcome Measure Information:
    Title
    1. How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment?
    Description
    DW-MRI to detect lesions
    Time Frame
    7 days after acute stroke
    Secondary Outcome Measure Information:
    Title
    2. How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment and how many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days?
    Description
    DW-MRI to detect lesions
    Time Frame
    30 days after acute stroke

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: LAA stroke or TIA ERILs or SNILs detected in initialDW-MRI signed informed consent Exclusion Criteria: planned surgical intervention iv Thrombolysis atrial fibrillation contra indications against DW-MRI

    12. IPD Sharing Statement

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