ERILs Und SNILs Unter SOC

Not Applicable

Withdrawn

• Conditions: Stroke, Acute
• Interventions: Diagnostic Test: diffusion-weighted magnetic resonance imaging

• Registration Number: NCT05786170
• Lead Sponsor: Medical University of Vienna

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)?

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 Timeline

• Study Start: 2019-09
• Primary Completion: 2021-07-05
• Study Completion: 2021-07-05
• Status Verified: 2023-03
• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-14
• Last Update Submitted: 2023-03-14
• Study First Posted: 2023-03-27
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• LAA stroke or TIA
• ERILs or SNILs detected in initialDW-MRI
• signed informed consent

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Exclusion Criteria

• planned surgical intervention
• iv Thrombolysis
• atrial fibrillation
• contra indications against DW-MRI

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
magnetic resonance imaging	diffusion-weighted magnetic resonance imaging	DW-MRI after ischemic stroke

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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