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Withdrawn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
About this trial
This is an interventional diagnostic trial for Stroke, Acute
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
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
NCT ID
NCT05786170
First Posted
March 14, 2023
Last Updated
March 14, 2023
Sponsor
Medical University of Vienna
Collaborators
Medical University Innsbruck
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Withdrawn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
Learn more about this trial
ERILs Und SNILs Unter SOC
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