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ERILs Und SNILs Unter SOC

Sponsor
Medical University of Vienna (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05786170
Collaborator
Medical University Innsbruck (Other)
0
Enrollment
1
Arm
22.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

  1. How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment?

  2. How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment?

  3. How many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days?

  4. Are there relevant risk faktors for the occurence of ERILs and SNILs (eg Diabetes or Biomarkers)?

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: diffusion-weighted magnetic resonance imaging
 N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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)
Anticipated Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Jul 5, 2021
Actual Study Completion Date :
Jul 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: magnetic resonance imaging

DW-MRI after ischemic stroke

Diagnostic Test: diffusion-weighted magnetic resonance imaging
diffusion-weighted magnetic resonance imaging

Outcome Measures

Primary Outcome Measures

  1. 1. How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment? [7 days after acute stroke]

    DW-MRI to detect lesions

Secondary Outcome Measures

  1. 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? [30 days after acute stroke]

    DW-MRI to detect lesions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of Vienna
  • Medical University Innsbruck

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christa Firbas MD, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT05786170
Other Study ID Numbers:
  • ERILs und SNILs unter SOC
First Posted:
Mar 27, 2023
Last Update Posted:
Mar 27, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Mar 27, 2023