ERILs Und SNILs Unter SOC

Stroke, Acute Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05786170
• Other study ID #: ERILs und SNILs unter SOC
• Status: Withdrawn
• Phase: N/A
• Start date: September 2019
• Est. completion date: July 5, 2021

Study information

• Verified date: March 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)?

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 5, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Medical University Innsbruck

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment?	DW-MRI to detect lesions	7 days after acute stroke
Secondary	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	30 days after acute stroke