ERILs Und SNILs Unter SOC

March 14, 2023 updated by: Christa Firbas MD, Medical University of Vienna

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)

  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)?

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: magnetic resonance imaging
DW-MRI after ischemic stroke
Diagnostic test: diffusion-weighted magnetic resonance imaging
diffusion-weighted magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment?
Time Frame: 7 days after acute stroke
DW-MRI to detect lesions
7 days after acute stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
Time Frame: 30 days after acute stroke
DW-MRI to detect lesions
30 days after acute stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Actual)

July 5, 2021

Study Completion (Actual)

July 5, 2021

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERILs und SNILs unter SOC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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